<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/NCT03248141</url>
  </required_header>
  <id_info>
    <org_study_id>B1821056</org_study_id>
    <secondary_id>HEMOBAFS</secondary_id>
    <nct_id>NCT03248141</nct_id>
  </id_info>
  <brief_title>Understanding Hemophilia A and B Drug Dosage Administration Patterns</brief_title>
  <official_title>UNDERSTANDING HEMOPHILIA A AND B DRUG DOSAGE ADMINISTRATION PATTERNS</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Design&#xD;
&#xD;
      A prospective observational, cross-sectional epidemiological study in U.S. site-based&#xD;
      clinical practice settings.&#xD;
&#xD;
      30 sites will enroll approximately 300 patients&#xD;
&#xD;
      Participating patients - or their caregiver in the case of patients under the age of 18 -&#xD;
      will be consented to participate.&#xD;
&#xD;
      Physicians complete a retrospective chart review on each enrolled patient.&#xD;
&#xD;
      Patients will complete a one-time study questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study recruitment was stopped due to difficulty in enrolling the targeted number of patients&#xD;
      on March 21, 2018. Subjects currently enrolled into the study have completed the study as per&#xD;
      protocol. There were no safety concerns involved in the decision to stop enrollment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on&#xD;
    March 21, 2018. See details in Description section.&#xD;
  </why_stopped>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">March 14, 2018</completion_date>
  <primary_completion_date type="Actual">March 14, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Resource Utilization Pattern</measure>
    <time_frame>From baseline up to end of study (6 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Dosing Pattern</measure>
    <time_frame>From baseline up to end of study (6 months)</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Hemophilia A</condition>
  <condition>Hemophilia B</condition>
  <arm_group>
    <arm_group_label>Hemophilia B</arm_group_label>
    <description>real world administration patterns and resource utilization implications</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Hemophilia A</arm_group_label>
    <description>real world administration patterns and resource utilization implications</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hemophilia B standard half-life</intervention_name>
    <description>Benefix</description>
    <arm_group_label>Hemophilia B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hemophilia B extended half-life</intervention_name>
    <description>Alprolix</description>
    <arm_group_label>Hemophilia B</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hemophilia A standard half-life</intervention_name>
    <description>Xyntha and other standard half-life agents</description>
    <arm_group_label>Hemophilia A</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Hemophilia A extended half-life</intervention_name>
    <description>Eloctate and Adynovate</description>
    <arm_group_label>Hemophilia A</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients diagnosed with either hemophilia A or B who present for a routine Clinical visit&#xD;
        will be asked to participate in the study by the treating physician at participating&#xD;
        hemophilia treatment centers in the United States of America.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Physician/Clinician Participants:&#xD;
&#xD;
          -  Must be a healthcare provider&#xD;
&#xD;
          -  Currently manages at least 10 hemophilia A and/or B patients&#xD;
&#xD;
        Patient Participants:&#xD;
&#xD;
          -  Willing and able to provide informed consent&#xD;
&#xD;
          -  Diagnosed with hemophilia A or B&#xD;
&#xD;
          -  Current disease severity is either moderately severe or severe with a clotting factor&#xD;
             level of ≤5%&#xD;
&#xD;
          -  If suffering from hemophilia A, must be currently taking moroctocog alfa (or another&#xD;
             standard half-life treatment), rurioctocog alfa or efraloctocog alfa for at least six&#xD;
             months.&#xD;
&#xD;
        (If currently taking rurioctocog alfa or efraloctocog alfa, must have been switched from a&#xD;
        standard half-life treatment and had been on that prior treatment for at least six months).&#xD;
&#xD;
          -  If suffering from hemophilia B, must be currently taking nonacog alfa or eftrenonacog&#xD;
             alfa for at least six months (If currently taking eftrenonacog alfa, must have&#xD;
             switched from nonacog alfa and had been on that prior treatment for at least six&#xD;
             months).&#xD;
&#xD;
          -  Infuse at least 3 times per month&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Female with hemophilia A or B&#xD;
&#xD;
          -  Mild Haemophilia A or B&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</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>University of Florida College of Medicine</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Childhood Diseases, dba Hemophilia Treatment Center of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cook Children's Medical Center</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1821056&amp;StudyName=Understanding+Hemophilia+A+And+B+Drug+Dosage+Administration+Patterns</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>May 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <results_first_submitted>February 22, 2019</results_first_submitted>
  <results_first_submitted_qc>February 22, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 20, 2019</results_first_posted>
  <last_update_submitted>February 22, 2019</last_update_submitted>
  <last_update_submitted_qc>February 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hemophilia A Factor VIII</keyword>
  <keyword>Hemophilia B Factor IX</keyword>
  <keyword>Cross-sectional</keyword>
  <keyword>Epidemiological</keyword>
  <keyword>Clinical practice</keyword>
  <keyword>United States</keyword>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Factor VIII</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 4, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03248141/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03248141/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Out of 41 screened participants, 11 were enrolled in this study. Study got terminated afterwards due to difficulty in enrolling the targeted number of participants.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Hemophilia A Cohort</title>
          <description>Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [&lt;=]5 percent[%] or severe: clotting factor level of less than [&lt;]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.</description>
        </group>
        <group group_id="P2">
          <title>Hemophilia B Cohort</title>
          <description>Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level &lt;=5% or severe: clotting factor level of &lt;1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="0">No enrollment occurred in this arm prior to study termination.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11">Participants who were present in the study till termination were considered as completed.</participants>
                <participants group_id="P2" count="0"/>
              </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>Analysis population included all enrolled participants.</population>
      <group_list>
        <group group_id="B1">
          <title>Hemophilia A Cohort</title>
          <description>Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [&lt;=]5 percent[%] or severe: clotting factor level of less than [&lt;]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.</description>
        </group>
        <group group_id="B2">
          <title>Hemophilia B Cohort</title>
          <description>Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level &lt;=5% or severe: clotting factor level of &lt;1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.</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="11"/>
            <count group_id="B2" value="0"/>
            <count group_id="B3" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</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_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="11"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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="11"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Resource Utilization Pattern</title>
        <time_frame>From baseline up to end of study (6 months)</time_frame>
        <population>Data was not collected and analyzed for this outcome measure since very less number of participants were enrolled prior to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Hemophilia A Cohort</title>
            <description>Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [&lt;=]5 percent[%] or severe: clotting factor level of less than [&lt;]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.</description>
          </group>
          <group group_id="O2">
            <title>Hemophilia B Cohort</title>
            <description>Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level &lt;=5% or severe: clotting factor level of &lt;1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Resource Utilization Pattern</title>
          <population>Data was not collected and analyzed for this outcome measure since very less number of participants were enrolled prior to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Dosing Pattern</title>
        <time_frame>From baseline up to end of study (6 months)</time_frame>
        <population>Data was not collected and analyzed for this outcome measure since very less number of participants were enrolled prior to study termination.</population>
        <group_list>
          <group group_id="O1">
            <title>Hemophilia A Cohort</title>
            <description>Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [&lt;=]5 percent[%] or severe: clotting factor level of less than [&lt;]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.</description>
          </group>
          <group group_id="O2">
            <title>Hemophilia B Cohort</title>
            <description>Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level &lt;=5% or severe: clotting factor level of &lt;1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.</description>
          </group>
        </group_list>
        <measure>
          <title>Dosing Pattern</title>
          <population>Data was not collected and analyzed for this outcome measure since very less number of participants were enrolled prior to study termination.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From baseline up to 6 months</time_frame>
      <desc>No enrollment occurred in Hemophilia B Cohort prior to study termination.</desc>
      <group_list>
        <group group_id="E1">
          <title>Hemophilia A Cohort</title>
          <description>Participants diagnosed with Hemophilia A (disease severity either moderate: clotting factor level of less than and equal to [&lt;=]5 percent[%] or severe: clotting factor level of less than [&lt;]1%), and taking Xyntha or another standard half-life treatment (Adynovate or Eloctate) for at least 6 months (if taking Adynovate or Eloctate, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months and must have infused at least 3 times per month) were observed in this study for up to 6 months.</description>
        </group>
        <group group_id="E2">
          <title>Hemophilia B Cohort</title>
          <description>Participants diagnosed with Hemophilia B (disease severity either moderate: clotting factor level &lt;=5% or severe: clotting factor level of &lt;1%), and taking BeneFIX or Alprolix for at least 6 months (if received Alprolix, must had switched from BeneFIX and had been on that prior treatment for at least 6 months and must have infused at least 3 times per month), were observed in this study for up to 6 months.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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>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>
    <limitations_and_caveats>Since study terminated early due to difficulty in enrolling targeted number of participants, so data was not collected and analyzed for any secondary endpoints, hence not reported in results. No safety concerns involved in decision to stop enrollment</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Pfizer ClinicalTrials.gov Call Center</name_or_title>
      <organization>Pfizer Inc.</organization>
      <phone>1-800-718-1021</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/NCT03248141
org study id: B1821056
secondary id: HEMOBAFS
nct id: NCT03248141
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Study Design

      A prospective observational, cross-sectional epidemiological study in U.S. site-based
      clinical practice settings.

      30 sites will enroll approximately 300 patients

      Participating patients - or their caregiver in the case of patients under the age of 18 -
      will be consented to participate.

      Physicians complete a retrospective chart review on each enrolled patient.

      Patients will complete a one-time study questionnaire.
Study recruitment was stopped due to difficulty in enrolling the targeted number of patients
      on March 21, 2018. Subjects currently enrolled into the study have completed the study as per
      protocol. There were no safety concerns involved in the decision to stop enrollment.
observational model: Cohort
time perspective: Other
measure: Resource Utilization Pattern
time frame: From baseline up to end of study (6 months)
measure: Dosing Pattern
time frame: From baseline up to end of study (6 months)
arm group label: Hemophilia B
description: real world administration patterns and resource utilization implications
arm group label: Hemophilia A
description: real world administration patterns and resource utilization implications
intervention type: Drug
intervention name: Hemophilia B standard half-life
description: Benefix
arm group label: Hemophilia B
intervention type: Drug
intervention name: Hemophilia B extended half-life
description: Alprolix
arm group label: Hemophilia B
intervention type: Drug
intervention name: Hemophilia A standard half-life
description: Xyntha and other standard half-life agents
arm group label: Hemophilia A
intervention type: Drug
intervention name: Hemophilia A extended half-life
description: Eloctate and Adynovate
arm group label: Hemophilia A
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
facility: 
facility: 
facility: 
country: United States
url: https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1821056&StudyName=Understanding+Hemophilia+A+And+B+Drug+Dosage+Administration+Patterns
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
mesh term: Factor VIII
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Since study terminated early due to difficulty in enrolling targeted number of participants, so data was not collected and analyzed for any secondary endpoints, hence not reported in results. No safety concerns involved in decision to stop enrollment
point of contact: 