<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01662531</url>
  </required_header>
  <id_info>
    <org_study_id>CSL654_3002</org_study_id>
    <secondary_id>2011-006032-23</secondary_id>
    <nct_id>NCT01662531</nct_id>
  </id_info>
  <brief_title>A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B</brief_title>
  <official_title>A Phase III Open-label, Multicenter, Pharmacokinetic, Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Previously Treated Children With Hemophilia B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CSL Behring</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>CSL Behring</source>
  <brief_summary>
    <textblock>
      This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control&#xD;
      and prevention of bleeding episodes in children who have previously received factor&#xD;
      replacement therapy for hemophilia B.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product</measure>
    <time_frame>30 minutes after infusion</time_frame>
    <description>Incremental recovery (IU/dL/IU/kg) is defined as the FIX activity (IU/dL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method. Recovery values were baseline-corrected for pre-infusion plasma FIX activity. Incremental recovery was measured following a single intravenous dose of 50 IU/kg rIX-FP on Day 1. Analysis of previous FIX product was conducted at the beginning of the study in a subset of subjects who had no historical pharmacokinetic (PK) data of their previous FIX product. For the PK assessment, the previous FIX product was administered by IV infusion after approximately 4 days following the last FIX treatment, prior to any dosing of rIX-FP. The formal PK population consisted of subjects who received at least 1 dose of rIX-FP for PK assessment and for whom a sufficient number of analyzable PK samples had been obtained to permit the evaluation of the PK profile of rIX-FP.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product</measure>
    <time_frame>Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose</time_frame>
    <description>FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast)</measure>
    <time_frame>Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose</time_frame>
    <description>AUClast following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product.&#xD;
FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product</measure>
    <time_frame>Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose</time_frame>
    <description>FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values. Clearance is normalized for body weight.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Subjects Developing Inhibitors to Factor IX (FIX)</measure>
    <time_frame>12 months</time_frame>
    <description>Inhibitor formation was defined as any inhibitor (≥0.6 BU [Bethesda Units]/mL) identified and confirmed by retesting.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Treatment-related Adverse Events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects Developing Antibodies Against rIX-FP</measure>
    <time_frame>12 months</time_frame>
    <description>Antibodies to rIX-FP were measured using a direct-binding enzyme-linked immunosorbent assay (ELISA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis</measure>
    <time_frame>Approximately 12 months</time_frame>
    <description>For each bleeding episode that required treatment, the number of episodes that required one, two or more than two infusions of rIX-FP to achieve hemostasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consumption of rIX-FP During Routine Prophylaxis</measure>
    <time_frame>12 months</time_frame>
    <description>Consumption of rIX-FP during routine prophylaxis is expressed as the total prophylaxis dose per month.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Hemophilia B</condition>
  <arm_group>
    <arm_group_label>rIX-FP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) will be administered by IV infusion as routine weekly prophylaxis and episodic treatment for bleeding episodes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>rIX-FP</intervention_name>
    <description>Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)</description>
    <arm_group_label>rIX-FP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male subjects, younger than 12 years old.&#xD;
&#xD;
          -  Severe hemophilia B (Factor IX [FIX] activity of ≤ 2%).&#xD;
&#xD;
          -  Body weight ≥ 10 kg.&#xD;
&#xD;
          -  Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for &gt;&#xD;
             150 exposure days (EDs) (6 to &lt; 12 years), and &gt; 50 EDs (&lt; 6 years).&#xD;
&#xD;
          -  No history of FIX inhibitor formation, no detectable inhibitors at Screening and no&#xD;
             family history of inhibitors against FIX.&#xD;
&#xD;
          -  Written informed consent for study participation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known hypersensitivity to any FIX product or hamster protein.&#xD;
&#xD;
          -  Known congenital or acquired coagulation disorder other than congenital FIX&#xD;
             deficiency.&#xD;
&#xD;
          -  Kidney or liver disease.&#xD;
&#xD;
          -  Recent life-threatening bleeding episode.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>11 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Program Director</last_name>
    <role>Study Director</role>
    <affiliation>CSL Behring</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Royal Children's Hospital, Melbourne</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital at Westmead</name>
      <address>
        <city>Westmead</city>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH Wien (Paediatrics)</name>
      <address>
        <city>Wien</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McMaster Children's Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8N3Z5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Brno</name>
      <address>
        <city>Brno</city>
        <zip>625 00</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Ostrava</name>
      <address>
        <city>Ostrava</city>
        <zip>708 52</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Motole</name>
      <address>
        <city>Praha 5</city>
        <zip>150 06</zip>
        <country>Czech Republic</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>C.R.T.H. Hopital de Bicentre (Hemophilie)</name>
      <address>
        <city>Le Kremlin-Bicentre</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Edouard Herriot</name>
      <address>
        <city>Lyon</city>
        <zip>69437</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital d'enfants La Timone</name>
      <address>
        <city>Marseille</city>
        <zip>13385</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CRC Coagulation Research Center GmbH</name>
      <address>
        <city>Duisburg/Altstadt</city>
        <zip>47051</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel Hashomer</city>
        <zip>52621</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AOU Careggi</name>
      <address>
        <city>Firenze</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Ospendale Maggiore (Centro emofilia e Trombosi)</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FGU &quot;Kirov Research Institute of Haemotology and Blood Trans)</name>
      <address>
        <city>Kirov</city>
        <zip>610027</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>H.U. La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Canada</country>
    <country>Czech Republic</country>
    <country>France</country>
    <country>Germany</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Russian Federation</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 10, 2012</study_first_posted>
  <results_first_submitted>April 3, 2016</results_first_submitted>
  <results_first_submitted_qc>April 3, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 9, 2016</results_first_posted>
  <disposition_first_submitted>November 5, 2015</disposition_first_submitted>
  <disposition_first_submitted_qc>November 5, 2015</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">December 4, 2015</disposition_first_posted>
  <last_update_submitted>April 3, 2016</last_update_submitted>
  <last_update_submitted_qc>April 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 9, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemophilia A</mesh_term>
    <mesh_term>Hemophilia B</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Of the 18 sites that were activated, subjects were enrolled from 17 sites in 10 countries.</recruitment_details>
      <pre_assignment_details>Subjects &lt;12 years of age with severe hemophilia B (FIX activity of ≤2%) were planned to be enrolled in the study, including 11 to 12 subjects in each age group (6 to &lt;12 years and &lt;6 years of age). Of 29 subjects screened, 27 subjects were enrolled and treated with rIX-FP.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>rIX-FP</title>
          <description>Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) will be administered by IV infusion as routine weekly prophylaxis and episodic treatment for bleeding episodes.&#xD;
rIX-FP: Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All 27 subjects were included in the Safety, Pharmacokinetic and Efficacy populations.</population>
      <group_list>
        <group group_id="B1">
          <title>Age &lt; 6 Years</title>
          <description>Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
        </group>
        <group group_id="B2">
          <title>Age 6 to &lt;12 Years</title>
          <description>Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
            <count group_id="B2" value="15"/>
            <count group_id="B3" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.2" spread="1.70"/>
                    <measurement group_id="B2" value="8.1" spread="1.41"/>
                    <measurement group_id="B3" value="5.9" spread="2.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product</title>
        <description>Incremental recovery (IU/dL/IU/kg) is defined as the FIX activity (IU/dL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method. Recovery values were baseline-corrected for pre-infusion plasma FIX activity. Incremental recovery was measured following a single intravenous dose of 50 IU/kg rIX-FP on Day 1. Analysis of previous FIX product was conducted at the beginning of the study in a subset of subjects who had no historical pharmacokinetic (PK) data of their previous FIX product. For the PK assessment, the previous FIX product was administered by IV infusion after approximately 4 days following the last FIX treatment, prior to any dosing of rIX-FP. The formal PK population consisted of subjects who received at least 1 dose of rIX-FP for PK assessment and for whom a sufficient number of analyzable PK samples had been obtained to permit the evaluation of the PK profile of rIX-FP.</description>
        <time_frame>30 minutes after infusion</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>rIX-FP</title>
            <description>All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Age &lt; 6 Years</title>
            <description>Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O3">
            <title>Age 6 to &lt;12 Years</title>
            <description>Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product</title>
          <description>Incremental recovery (IU/dL/IU/kg) is defined as the FIX activity (IU/dL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method. Recovery values were baseline-corrected for pre-infusion plasma FIX activity. Incremental recovery was measured following a single intravenous dose of 50 IU/kg rIX-FP on Day 1. Analysis of previous FIX product was conducted at the beginning of the study in a subset of subjects who had no historical pharmacokinetic (PK) data of their previous FIX product. For the PK assessment, the previous FIX product was administered by IV infusion after approximately 4 days following the last FIX treatment, prior to any dosing of rIX-FP. The formal PK population consisted of subjects who received at least 1 dose of rIX-FP for PK assessment and for whom a sufficient number of analyzable PK samples had been obtained to permit the evaluation of the PK profile of rIX-FP.</description>
          <population>PK Population</population>
          <units>(IU/dL)/(IU/kg)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>rIX-FP Assessment (n = 27, 12, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0114" spread="0.22711"/>
                    <measurement group_id="O2" value="0.9506" spread="0.20432"/>
                    <measurement group_id="O3" value="1.0600" spread="0.23934"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Previous FIX Assessment (n = 17, 8, 9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7379" spread="0.19768"/>
                    <measurement group_id="O2" value="0.6764" spread="0.13980"/>
                    <measurement group_id="O3" value="0.7925" spread="0.23219"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product</title>
        <description>FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.</description>
        <time_frame>Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>rIX-FP</title>
            <description>All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Age &lt; 6 Years</title>
            <description>Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O3">
            <title>Age 6 to &lt;12 Years</title>
            <description>Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product</title>
          <description>FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.</description>
          <population>PK Population</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>rIX-FP Assessment (n = 26, 11, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.4492" spread="15.9754"/>
                    <measurement group_id="O2" value="89.6124" spread="11.17364"/>
                    <measurement group_id="O3" value="92.7962" spread="19.02537"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Previous FIX Assessment (n = 16, 7, 9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.6291" spread="6.15551"/>
                    <measurement group_id="O2" value="19.8816" spread="8.01073"/>
                    <measurement group_id="O3" value="17.6550" spread="4.52497"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast)</title>
        <description>AUClast following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product.&#xD;
FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.</description>
        <time_frame>Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>rIX-FP</title>
            <description>All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Age &lt; 6 Years</title>
            <description>Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O3">
            <title>Age 6 to &lt;12 Years</title>
            <description>Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast)</title>
          <description>AUClast following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product.&#xD;
FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.</description>
          <population>PK Population</population>
          <units>IU*hr/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>rIX-FP Assessment (n = 27, 12, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4156.7037" spread="1204.09549"/>
                    <measurement group_id="O2" value="3891.4820" spread="1252.99415"/>
                    <measurement group_id="O3" value="4368.8810" spread="1162.09967"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Previous FIX Assessment (n = 16, 7, 9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="718.9386" spread="230.52884"/>
                    <measurement group_id="O2" value="676.5414" spread="316.91381"/>
                    <measurement group_id="O3" value="751.9143" spread="146.70454"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product</title>
        <description>FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values. Clearance is normalized for body weight.</description>
        <time_frame>Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose</time_frame>
        <population>PK Population</population>
        <group_list>
          <group group_id="O1">
            <title>rIX-FP</title>
            <description>All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Age &lt; 6 Years</title>
            <description>Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O3">
            <title>Age 6 to &lt;12 Years</title>
            <description>Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product</title>
          <description>FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values. Clearance is normalized for body weight.</description>
          <population>PK Population</population>
          <units>mL/hr/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>rIX-FP Assessment (n = 26, 11, 15)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1119" spread="0.31373"/>
                    <measurement group_id="O2" value="1.1841" spread="0.32924"/>
                    <measurement group_id="O3" value="1.0589" spread="0.30203"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Previous FIX Assessment (n = 16, 7, 9)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4007" spread="2.14434"/>
                    <measurement group_id="O2" value="7.1576" spread="2.78944"/>
                    <measurement group_id="O3" value="5.8119" spread="1.37641"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Developing Inhibitors to Factor IX (FIX)</title>
        <description>Inhibitor formation was defined as any inhibitor (≥0.6 BU [Bethesda Units]/mL) identified and confirmed by retesting.</description>
        <time_frame>12 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>rIX-FP</title>
            <description>All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Developing Inhibitors to Factor IX (FIX)</title>
          <description>Inhibitor formation was defined as any inhibitor (≥0.6 BU [Bethesda Units]/mL) identified and confirmed by retesting.</description>
          <population>Safety Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects With Treatment-related Adverse Events</title>
        <time_frame>12 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>rIX-FP</title>
            <description>All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Treatment-related Adverse Events</title>
          <population>Safety Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Any adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Treatment-related adverse event</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Subjects Developing Antibodies Against rIX-FP</title>
        <description>Antibodies to rIX-FP were measured using a direct-binding enzyme-linked immunosorbent assay (ELISA).</description>
        <time_frame>12 months</time_frame>
        <population>Safety Population</population>
        <group_list>
          <group group_id="O1">
            <title>rIX-FP</title>
            <description>All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Developing Antibodies Against rIX-FP</title>
          <description>Antibodies to rIX-FP were measured using a direct-binding enzyme-linked immunosorbent assay (ELISA).</description>
          <population>Safety Population</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis</title>
        <description>For each bleeding episode that required treatment, the number of episodes that required one, two or more than two infusions of rIX-FP to achieve hemostasis</description>
        <time_frame>Approximately 12 months</time_frame>
        <population>Efficacy Population</population>
        <group_list>
          <group group_id="O1">
            <title>rIX-FP</title>
            <description>All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Age &lt; 6 Years</title>
            <description>Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O3">
            <title>Age 6 to &lt;12 Years</title>
            <description>Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis</title>
          <description>For each bleeding episode that required treatment, the number of episodes that required one, two or more than two infusions of rIX-FP to achieve hemostasis</description>
          <population>Efficacy Population</population>
          <units>bleeding episodes</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 infusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94"/>
                    <measurement group_id="O2" value="40"/>
                    <measurement group_id="O3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 infusions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="5"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt; 2 infusions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 or 2 infusions</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="103"/>
                    <measurement group_id="O2" value="45"/>
                    <measurement group_id="O3" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Consumption of rIX-FP During Routine Prophylaxis</title>
        <description>Consumption of rIX-FP during routine prophylaxis is expressed as the total prophylaxis dose per month.</description>
        <time_frame>12 months</time_frame>
        <population>Efficacy Population</population>
        <group_list>
          <group group_id="O1">
            <title>rIX-FP</title>
            <description>All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O2">
            <title>Age &lt; 6 Years</title>
            <description>Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
          <group group_id="O3">
            <title>Age 6 to &lt;12 Years</title>
            <description>Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
          </group>
        </group_list>
        <measure>
          <title>Consumption of rIX-FP During Routine Prophylaxis</title>
          <description>Consumption of rIX-FP during routine prophylaxis is expressed as the total prophylaxis dose per month.</description>
          <population>Efficacy Population</population>
          <units>IU/kg/month</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="12"/>
                <count group_id="O3" value="15"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="205.071" spread="41.1550"/>
                    <measurement group_id="O2" value="213.517" spread="44.3848"/>
                    <measurement group_id="O3" value="198.314" spread="38.5693"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>Treatment-emergent adverse events, defined as adverse events present prior to the first dose of rIX-FP that subsequently worsened in severity or those that were not present prior to the first dose but subsequently appeared are summarized.</desc>
      <group_list>
        <group group_id="E1">
          <title>rIX-FP</title>
          <description>All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.&#xD;
Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (14.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Forearm fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Tongue injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Groin pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (14.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dental discomfort</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Toothache</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="14" subjects_affected="9" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Bronchitis</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Viral infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Molluscum contagiosum</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="9" subjects_affected="5" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Injury</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Head injury</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>CSL agreements and restrictions on publishing may vary with individual investigators; however, CSL will not prohibit any investigator from publishing. CSL supports the publication of results from all centers of a multi-center trial and generally requires that reports based on single-site data not precede the primary publication of the entire clinical trial.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Clinical Trial Disclosure Manager</name_or_title>
      <organization>CSL Behring</organization>
      <phone>Use email contact</phone>
      <email>clinicaltrials@cslbehring.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01662531
org study id: CSL654_3002
secondary id: 2011-006032-23
nct id: NCT01662531
lead sponsor: 
This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control
      and prevention of bleeding episodes in children who have previously received factor
      replacement therapy for hemophilia B.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incremental Recovery Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product
time frame: 30 minutes after infusion
description: Incremental recovery (IU/dL/IU/kg) is defined as the FIX activity (IU/dL) obtained 30 minutes following infusion, per dose of (IU/kg) infusion. FIX activity was measured at a central laboratory using validated one-stage clotting method. Recovery values were baseline-corrected for pre-infusion plasma FIX activity. Incremental recovery was measured following a single intravenous dose of 50 IU/kg rIX-FP on Day 1. Analysis of previous FIX product was conducted at the beginning of the study in a subset of subjects who had no historical pharmacokinetic (PK) data of their previous FIX product. For the PK assessment, the previous FIX product was administered by IV infusion after approximately 4 days following the last FIX treatment, prior to any dosing of rIX-FP. The formal PK population consisted of subjects who received at least 1 dose of rIX-FP for PK assessment and for whom a sufficient number of analyzable PK samples had been obtained to permit the evaluation of the PK profile of rIX-FP.
measure: Half-life (t1/2) Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product
time frame: Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose
description: FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.
measure: Area Under the Concentration Versus Time Curve From Time Point Zero to the Last Sample With Quantifiable Drug Concentration (AUClast)
time frame: Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose
description: AUClast following a single intravenous dose of 50 IU/kg rIX-FP or previous FIX product.
FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values.
measure: Clearance for FIX Activity Following a Single Intravenous Dose of 50 IU/kg rIX-FP or Previous FIX Product
time frame: Pre-dose, 30 minutes, 3, 24, 48, 72 120, 168, 240 and 336 hours post-dose
description: FIX activity was measured at a central laboratory using validated one-stage clotting method. FIX levels were not corrected for baseline values. Clearance is normalized for body weight.
measure: Number of Subjects Developing Inhibitors to Factor IX (FIX)
time frame: 12 months
description: Inhibitor formation was defined as any inhibitor (≥0.6 BU [Bethesda Units]/mL) identified and confirmed by retesting.
measure: Number of Subjects With Treatment-related Adverse Events
time frame: 12 months
measure: Number of Subjects Developing Antibodies Against rIX-FP
time frame: 12 months
description: Antibodies to rIX-FP were measured using a direct-binding enzyme-linked immunosorbent assay (ELISA).
measure: Number of Bleeding Episodes Requiring One, Two or More Than Two Infusions of rIX-FP to Achieve Hemostasis
time frame: Approximately 12 months
description: For each bleeding episode that required treatment, the number of episodes that required one, two or more than two infusions of rIX-FP to achieve hemostasis
measure: Consumption of rIX-FP During Routine Prophylaxis
time frame: 12 months
description: Consumption of rIX-FP during routine prophylaxis is expressed as the total prophylaxis dose per month.
arm group label: rIX-FP
arm group type: Experimental
description: Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) will be administered by IV infusion as routine weekly prophylaxis and episodic treatment for bleeding episodes.
intervention type: Biological
intervention name: rIX-FP
description: Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)
arm group label: rIX-FP
criteria: 
gender: Male
minimum age: N/A
maximum age: 11 Years
healthy volunteers: No
last name: Program Director
role: Study Director
affiliation: CSL Behring
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country: Australia
country: Austria
country: Canada
country: Czech Republic
country: France
country: Germany
country: Israel
country: Italy
country: Russian Federation
country: Spain
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Hemophilia B
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 