<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/NCT02213250</url>
  </required_header>
  <id_info>
    <org_study_id>B1821048</org_study_id>
    <secondary_id>2015-003027-61</secondary_id>
    <nct_id>NCT02213250</nct_id>
  </id_info>
  <brief_title>An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B</brief_title>
  <official_title>An Open-label, Single Dose Pharmacokinetic Study Of Benefix (Nonacog Alfa, Recombinant Factor Ix) In Male Chinese Subjects With Hemophilia B</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK&#xD;
      study and to support the registration in China.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">April 2015</primary_completion_date>
  <phase>Phase 1</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>Maximum Observed Plasma Concentration (Cmax)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinf)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to Reach Cmax (Tmax)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of Distribution at Steady State (Vss)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
    <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Terminal Phase Rate Constant (Kel)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
    <description>Linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean Residence Time (MRT)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
    <description>AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Plasma Decay Half-Life (t½)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
    <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Systemic Clearance (CL)</measure>
    <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
    <description>CL is a quantitative measure of the rate at which a drug substance is removed from the body.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incremental Recovery</measure>
    <time_frame>Pre-dose, 0.25, 0.5 and 1 hour post-dose</time_frame>
    <description>Incremental recovery: Increase in circulating increase in FIX activity for every IU of BeneFIX administered per kg of body weight.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Withdrawals Due to Adverse Events (AE)</measure>
    <time_frame>From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.</time_frame>
    <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAE is defined as newly occurring or worsening after first dose.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Abnormal Clinical Laboratory Measurements (Without Regard to Baseline Abnormality)</measure>
    <time_frame>Baseline up to 96 hours post-dose (Day 5 or early termination)</time_frame>
    <description>Clinical laboratory analysis tests included hematology, serium chemistry, prothrombin time and urianalysis. Numbers of subjects with laboratory test abnormalities without regard to baseline abnormality were reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Vital Signs Post-Dose Data Met Criteria of Potential Clinical Concern (Without Regard to Baseline Abnormality)</measure>
    <time_frame>Baseline up to 96 hours post-dose (Day 5 or early termination)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Inhibitor Development</measure>
    <time_frame>From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Allergic Reactions</measure>
    <time_frame>From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Subjects With Thrombogenicity</measure>
    <time_frame>From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Hemophilia B</condition>
  <arm_group>
    <arm_group_label>BeneFIX</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BENEFIX</intervention_name>
    <description>Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.</description>
    <arm_group_label>BeneFIX</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male Chinese subjects 6 years or older (weight ≥20kg) with moderate to severe&#xD;
             hemophilia B (Factor IX activity ≤2%).&#xD;
&#xD;
          -  Subjects should not have received an infusion of any Factor IX products for at least 4&#xD;
             days before the administration of BeneFIX on Day 1.&#xD;
&#xD;
          -  Subjects must be in a non-bleeding state before the administration of BeneFIX on Day&#xD;
             1.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence or history of clinically significant hematological, renal, endocrine,&#xD;
             pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or&#xD;
             allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal&#xD;
             allergies at time of dosing) disease or clinical findings at Screening.&#xD;
&#xD;
          -  Diagnosed with any other bleeding disorder in addition to hemophilia B.&#xD;
&#xD;
          -  Current FIX inhibitor or history of FIX inhibitor (defined as &gt; Upper Limit of Normal&#xD;
             (ULN) of the reporting lab).&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology Department,Beijing Children's Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100045</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1821048&amp;StudyName=An%20Open-Label%2C%20Single%20Dose%20Pharmacokinetic%20Study%20of%20Benefix%20%28Recombinant%20Factor%20IX%29%20in%20Male%20Chinese%20Subjects%20with%20Hemophilia%20B%20</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>May 4, 2016</results_first_submitted>
  <results_first_submitted_qc>June 13, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">July 25, 2016</results_first_posted>
  <last_update_submitted>June 13, 2016</last_update_submitted>
  <last_update_submitted_qc>June 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 25, 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>Twelve (12) participants that were age 6 years or older (weight ≥20 kg) with moderate severe to severe hemophilia B (FIX activity ≤2%) were enrolled. Four (4) participants were at the younger age range of ≥6 and &lt;12 years; remaining participants were 12 years or older.</recruitment_details>
      <pre_assignment_details>Participants did not receive an infusion of any FIX products for at least 4 days and were required to be in a non-bleeding state before the administration of BeneFIX on Day 1.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>BeneFIX 50 IU/kg; Age Group: &gt;=6 and &lt;12 Years</title>
          <description>Participants received a single dose of 50 IU/kg BeneFIX administered by intravenous (IV) infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
        </group>
        <group group_id="P2">
          <title>BeneFIX 50 IU/kg; Age Group: &gt;=12 Years</title>
          <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants were included in the baseline population.</population>
      <group_list>
        <group group_id="B1">
          <title>All Participants</title>
          <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </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="24.8" spread="15.4"/>
                  </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_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Observed Plasma Concentration (Cmax)</title>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
        <population>The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg; &gt;=6 and &lt;12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>BeneFIX 50 IU/kg; Age Group:&gt;=12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Observed Plasma Concentration (Cmax)</title>
          <population>The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
          <units>IU/milliliter (IU/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.3880" spread="26"/>
                    <measurement group_id="O2" value="0.4226" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)</title>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
        <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg; &gt;=6 and &lt;12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>BeneFIX 50 IU/kg; Age Group:&gt;=12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)</title>
          <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
          <units>IU*hour/milliliter (IU*hr/mL)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.930" spread="18"/>
                    <measurement group_id="O2" value="9.707" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinf)</title>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
        <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg; Age Group&gt;=6 and &lt;12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>BeneFIX 50 IU/kg; Age Group:&gt;=12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinf)</title>
          <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
          <units>IU*hr/ml</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.841" spread="16"/>
                    <measurement group_id="O2" value="11.66" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Time to Reach Cmax (Tmax)</title>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
        <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg; &gt;=6 and &lt;12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>BeneFIX 50 IU/kg; Age Group:&gt;=12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Reach Cmax (Tmax)</title>
          <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.500" lower_limit="0.250" upper_limit="3.00"/>
                    <measurement group_id="O2" value="0.375" lower_limit="0.250" upper_limit="3.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Volume of Distribution at Steady State (Vss)</title>
        <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
        <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg; &gt;=6 and &lt;12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>BeneFIX 50 IU/kg; Age Group:&gt;=12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Volume of Distribution at Steady State (Vss)</title>
          <description>Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.</description>
          <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
          <units>milliliter/kilogram (mL/kg)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="227.9" spread="20"/>
                    <measurement group_id="O2" value="218.8" spread="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Terminal Phase Rate Constant (Kel)</title>
        <description>Linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
        <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg; &gt;=6 and &lt;12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>BeneFIX 50 IU/kg; Age Group:&gt;=12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Terminal Phase Rate Constant (Kel)</title>
          <description>Linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.</description>
          <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
          <units>1/hr</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.02509" spread="16"/>
                    <measurement group_id="O2" value="0.01781" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Mean Residence Time (MRT)</title>
        <description>AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
        <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg; &gt;=6 and &lt;12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>BeneFIX 50 IU/kg; Age Group:&gt;=12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Residence Time (MRT)</title>
          <description>AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.</description>
          <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
          <units>hours</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.78" spread="14"/>
                    <measurement group_id="O2" value="51.01" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Plasma Decay Half-Life (t½)</title>
        <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
        <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg; &gt;=6 and &lt;12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>BeneFIX 50 IU/kg; Age Group:&gt;=12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Plasma Decay Half-Life (t½)</title>
          <description>Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.</description>
          <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis 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="4"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.88" spread="4.4903"/>
                    <measurement group_id="O2" value="39.56" spread="7.3832"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Systemic Clearance (CL)</title>
        <description>CL is a quantitative measure of the rate at which a drug substance is removed from the body.</description>
        <time_frame>Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose</time_frame>
        <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg; &gt;=6 and &lt;12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>BeneFIX 50 IU/kg; Age Group:&gt;=12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Systemic Clearance (CL)</title>
          <description>CL is a quantitative measure of the rate at which a drug substance is removed from the body.</description>
          <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
          <units>mL/hr/kg</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.378" spread="16"/>
                    <measurement group_id="O2" value="4.291" spread="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Incremental Recovery</title>
        <description>Incremental recovery: Increase in circulating increase in FIX activity for every IU of BeneFIX administered per kg of body weight.</description>
        <time_frame>Pre-dose, 0.25, 0.5 and 1 hour post-dose</time_frame>
        <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg; &gt;=6 and &lt;12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
          <group group_id="O2">
            <title>BeneFIX 50 IU/kg; Age Group:&gt;=12 Years</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Incremental Recovery</title>
          <description>Incremental recovery: Increase in circulating increase in FIX activity for every IU of BeneFIX administered per kg of body weight.</description>
          <population>The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.</population>
          <units>(IU/dL)/(IU/Kg)</units>
          <param>Geometric Mean</param>
          <dispersion>Geometric Coefficient of Variation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7759" spread="26"/>
                    <measurement group_id="O2" value="0.8199" spread="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Withdrawals Due to Adverse Events (AE)</title>
        <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAE is defined as newly occurring or worsening after first dose.</description>
        <time_frame>From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.</time_frame>
        <population>The safety analysis set was defined as all participants who received at least 1 dose of BeneFIX.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Withdrawals Due to Adverse Events (AE)</title>
          <description>An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAE is defined as newly occurring or worsening after first dose.</description>
          <population>The safety analysis set was defined as all participants who received at least 1 dose of BeneFIX.</population>
          <units>Particpants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </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 Participants With Abnormal Clinical Laboratory Measurements (Without Regard to Baseline Abnormality)</title>
        <description>Clinical laboratory analysis tests included hematology, serium chemistry, prothrombin time and urianalysis. Numbers of subjects with laboratory test abnormalities without regard to baseline abnormality were reported.</description>
        <time_frame>Baseline up to 96 hours post-dose (Day 5 or early termination)</time_frame>
        <population>The safety analysis population included All participants who received at least 1 dose of BeneFIX.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Abnormal Clinical Laboratory Measurements (Without Regard to Baseline Abnormality)</title>
          <description>Clinical laboratory analysis tests included hematology, serium chemistry, prothrombin time and urianalysis. Numbers of subjects with laboratory test abnormalities without regard to baseline abnormality were reported.</description>
          <population>The safety analysis population included All participants who received at least 1 dose of BeneFIX.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Vital Signs Post-Dose Data Met Criteria of Potential Clinical Concern (Without Regard to Baseline Abnormality)</title>
        <time_frame>Baseline up to 96 hours post-dose (Day 5 or early termination)</time_frame>
        <population>The safety analysis population included All participants who received at least 1 dose of BeneFIX.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Vital Signs Post-Dose Data Met Criteria of Potential Clinical Concern (Without Regard to Baseline Abnormality)</title>
          <population>The safety analysis population included All participants who received at least 1 dose of BeneFIX.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Inhibitor Development</title>
        <time_frame>From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.</time_frame>
        <population>The safety analysis population included All participants who received at least 1 dose of BeneFIX.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Inhibitor Development</title>
          <population>The safety analysis population included All participants who received at least 1 dose of BeneFIX.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </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 Participants With Allergic Reactions</title>
        <time_frame>From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.</time_frame>
        <population>The safety analysis population included All participants who received at least 1 dose of BeneFIX.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Allergic Reactions</title>
          <population>The safety analysis population included All participants who received at least 1 dose of BeneFIX.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </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 Thrombogenicity</title>
        <time_frame>From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.</time_frame>
        <population>The safety analysis population included All participants who received at least 1 dose of BeneFIX.</population>
        <group_list>
          <group group_id="O1">
            <title>BeneFIX 50 IU/kg</title>
            <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects With Thrombogenicity</title>
          <population>The safety analysis population included All participants who received at least 1 dose of BeneFIX.</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </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_list>

    <reported_events>
      <time_frame>From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>BeneFIX 50 IU/kg</title>
          <description>Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0.05</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </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>Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer, Inc</organization>
      <phone>(001)8007181021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.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/NCT02213250
org study id: B1821048
secondary id: 2015-003027-61
nct id: NCT02213250
lead sponsor: 
has dmc: No
The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK
      study and to support the registration in China.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Observed Plasma Concentration (Cmax)
time frame: Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose
measure: Area Under the Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)
time frame: Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose
measure: Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinf)
time frame: Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose
measure: Time to Reach Cmax (Tmax)
time frame: Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose
measure: Volume of Distribution at Steady State (Vss)
time frame: Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose
description: Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.
measure: Terminal Phase Rate Constant (Kel)
time frame: Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose
description: Linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.
measure: Mean Residence Time (MRT)
time frame: Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose
description: AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.
measure: Plasma Decay Half-Life (t½)
time frame: Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose
description: Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
measure: Systemic Clearance (CL)
time frame: Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose
description: CL is a quantitative measure of the rate at which a drug substance is removed from the body.
measure: Incremental Recovery
time frame: Pre-dose, 0.25, 0.5 and 1 hour post-dose
description: Incremental recovery: Increase in circulating increase in FIX activity for every IU of BeneFIX administered per kg of body weight.
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Withdrawals Due to Adverse Events (AE)
time frame: From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.
description: An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAE is defined as newly occurring or worsening after first dose.
measure: Number of Participants With Abnormal Clinical Laboratory Measurements (Without Regard to Baseline Abnormality)
time frame: Baseline up to 96 hours post-dose (Day 5 or early termination)
description: Clinical laboratory analysis tests included hematology, serium chemistry, prothrombin time and urianalysis. Numbers of subjects with laboratory test abnormalities without regard to baseline abnormality were reported.
measure: Number of Participants With Vital Signs Post-Dose Data Met Criteria of Potential Clinical Concern (Without Regard to Baseline Abnormality)
time frame: Baseline up to 96 hours post-dose (Day 5 or early termination)
measure: Number of Participants With Inhibitor Development
time frame: From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.
measure: Number of Participants With Allergic Reactions
time frame: From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.
measure: Number of Subjects With Thrombogenicity
time frame: From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.
arm group label: BeneFIX
arm group type: Experimental
intervention type: Drug
intervention name: BENEFIX
description: Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.
arm group label: BeneFIX
criteria: 
gender: Male
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
country: China
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1821048&StudyName=An%20Open-Label%2C%20Single%20Dose%20Pharmacokinetic%20Study%20of%20Benefix%20%28Recombinant%20Factor%20IX%29%20in%20Male%20Chinese%20Subjects%20with%20Hemophilia%20B%20
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Hemophilia A
mesh term: Hemophilia B
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 