<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/NCT01704521</url>
  </required_header>
  <id_info>
    <org_study_id>12053004</org_study_id>
    <secondary_id>R34HL109334</secondary_id>
    <nct_id>NCT01704521</nct_id>
  </id_info>
  <brief_title>Viral Kinetics in HCV Clearance in Subjects With Hemophilia</brief_title>
  <acronym>HCV/Hemophil</acronym>
  <official_title>Viral Kinetic Models of HCV Clearance in Hemophiliacs With Telaprevir</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kenneth Sherman</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vertex Pharmaceuticals Incorporated</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine viral dynamic responses in subjects with chronic hepatitis C and&#xD;
      hemophilia when treated with pegylated interferon + ribavirin and telaprevir.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with&#xD;
      hemophilia from participating.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Sustained Virological Response at Week 12 (SVR12)</measure>
    <time_frame>Post-treatment at week 12</time_frame>
    <description>Viral kinetic assessment using SVR 12 to either &quot;lead-in&quot; 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Chronic Hepatitis C</condition>
  <condition>Hemophilia</condition>
  <arm_group>
    <arm_group_label>Lead-In</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Lead-in</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegIntereron + Ribavirin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PegInterferon</intervention_name>
    <arm_group_label>Lead-In</arm_group_label>
    <arm_group_label>No Lead-in</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ribavirin</intervention_name>
    <arm_group_label>Lead-In</arm_group_label>
    <arm_group_label>No Lead-in</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Telaprevir</intervention_name>
    <arm_group_label>Lead-In</arm_group_label>
    <arm_group_label>No Lead-in</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hemophilia A or B&#xD;
&#xD;
          2. HCV RNA positive (PCR or branched-chain DNA Methods), Genotype 1 (a/b, mixed and&#xD;
             unknown subtype)&#xD;
&#xD;
          3. Chronic HCV infection evidenced by HCV serology, HCV RNA or liver enzyme abnormalities&#xD;
             present at least 6 months prior to enrollment&#xD;
&#xD;
          4. Liver biopsy or non-invasive marker that permits fibrosis staging within 12 months of&#xD;
             enrollment. If a biopsy was not performed within 1 year, non-invasive markers may be&#xD;
             utilized during screening period. Cirrhosis is not an exclusion factor&#xD;
&#xD;
          5. Age ≥ 18 years&#xD;
&#xD;
          6. Prior HCV treatment naïve or experienced&#xD;
&#xD;
          7. HCV viral load detectable during screening period&#xD;
&#xD;
          8. Absence of exclusion criteria&#xD;
&#xD;
          9. Sexually active subjects (both male and female) must agree and commit to the use of a&#xD;
             medically acceptable form of contraception for the duration of the study and for 6&#xD;
             months following the last dose of study medication. Medically acceptable forms of&#xD;
             contraception include oral contraceptives, injectable or implantable methods,&#xD;
             intrauterine devices or properly used barrier contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Hemoglobin &lt;11&#xD;
&#xD;
          2. Pregnancy (during screening period or any time during treatment)&#xD;
&#xD;
               1. females, that are planning to become pregnant or are breastfeeding&#xD;
&#xD;
               2. males, whose partner is pregnant or is planning to become pregnant&#xD;
&#xD;
          3. HIV Infection&#xD;
&#xD;
          4. Prior History of:&#xD;
&#xD;
               1. Hepatitis B (HBsAG negative - must have documentation of negative results within&#xD;
                  one year prior to enrollment or during screening period if not performed in that&#xD;
                  time window&#xD;
&#xD;
               2. Homozygotic alpha-1-anti-trypsin (a1AT) deficiency - documentation of a1AT level&#xD;
                  &lt;80 (at anytime prior to screening). If &lt;80, phenotype testing should not&#xD;
                  demonstrate zz phenotype. All other phenotypes are not exclusionary,&#xD;
&#xD;
               3. History of Homozygotic Genetic Hemochromatosis (at anytime prior to enrollment)&#xD;
                  with evidence of iron overload requiring phlebotomy,&#xD;
&#xD;
               4. Autoimmune markers (antinuclear antibody (ANA) and/or antismooth muscle antibody&#xD;
                  (ASMA)) &gt;1:160.&#xD;
&#xD;
               5. Any other significant liver disease or process (to be determined by the&#xD;
                  investigator). Non-alcoholic fatty-liver disease (NAFLD) is not an exclusion.&#xD;
&#xD;
          5. History of Decompensated liver disease evidenced by any prior history of hepatic&#xD;
             encephalopathy (Grade 2 or higher), ascites, variceal bleeding; Platelet count &lt;&#xD;
             100,000&#xD;
&#xD;
          6. Active thyroid disease (OK if on thyroid replacement with normal thyroid-stimulating&#xD;
             hormone (TSH); if TSH abnormal must have normal free thyroid index)&#xD;
&#xD;
          7. Chronic renal insufficiency, defined as creatinine clearance &lt; 50 ml/min. (estimated&#xD;
             by Modification of Diet in Renal Disease (MDRD) formula)&#xD;
&#xD;
          8. Life-threatening disease processes that could preclude completion of trial in opinion&#xD;
             of investigator.&#xD;
&#xD;
          9. Any condition which the investigator feels will preclude safe completion of the&#xD;
             treatment regimen including severe psychiatric disorders, active alcohol or&#xD;
             recreational drug abuse.&#xD;
&#xD;
         10. Inability to provide informed consent.&#xD;
&#xD;
         11. Use of systemic corticosteroids or immunomodulatory drugs within 1 month (Nasal&#xD;
             steroids are permitted.)&#xD;
&#xD;
         12. Uncontrolled seizure disorder (in opinion of investigator)&#xD;
&#xD;
         13. Concurrent autoimmune processes with active disease that may be exacerbated by&#xD;
             interferon-based therapies (e.g. Crohn's Disease, Rheumatoid arthritis) in the opinion&#xD;
             of the investigator. Psoriasis permitted if controlled with topical medications at the&#xD;
             time of study enrollment.&#xD;
&#xD;
         14. Use of prohibited medications (as described in the telaprevir package insert) within&#xD;
             14 days of the first dose of study medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kenneth E Sherman, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UC Physicians Company</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <results_first_submitted>February 3, 2015</results_first_submitted>
  <results_first_submitted_qc>March 26, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">April 6, 2015</results_first_posted>
  <last_update_submitted>March 26, 2015</last_update_submitted>
  <last_update_submitted_qc>March 26, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>Kenneth Sherman</investigator_full_name>
    <investigator_title>Kenneth E. Sherman, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Hepatitis C</keyword>
  <keyword>HCV</keyword>
  <keyword>Hemophilia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hepatitis C</mesh_term>
    <mesh_term>Hepatitis C, Chronic</mesh_term>
    <mesh_term>Hepatitis</mesh_term>
    <mesh_term>Hemophilia A</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ribavirin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>January 2013 through April 2014 at Digestive Diseases Research / University of Cincinnati</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Lead-In</title>
          <description>Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin</description>
        </group>
        <group group_id="P2">
          <title>No Lead-in</title>
          <description>No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </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>
      <group_list>
        <group group_id="B1">
          <title>Lead-In</title>
          <description>Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin.</description>
        </group>
        <group group_id="B2">
          <title>No Lead-in</title>
          <description>No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin.</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="3"/>
            <count group_id="B2" value="2"/>
            <count group_id="B3" value="5"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" lower_limit="38" upper_limit="54"/>
                    <measurement group_id="B2" value="37" lower_limit="27" upper_limit="47"/>
                    <measurement group_id="B3" value="47" lower_limit="27" upper_limit="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</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>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>Asian</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>Native Hawaiian or Other Pacific Islander</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>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</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>Unknown or Not Reported</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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Sustained Virological Response at Week 12 (SVR12)</title>
        <description>Viral kinetic assessment using SVR 12 to either &quot;lead-in&quot; 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment.</description>
        <time_frame>Post-treatment at week 12</time_frame>
        <population>See baseline characteristics</population>
        <group_list>
          <group group_id="O1">
            <title>Lead-In</title>
            <description>Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin</description>
          </group>
          <group group_id="O2">
            <title>No Lead-in</title>
            <description>No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration PegInterferon + Ribavirin</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Sustained Virological Response at Week 12 (SVR12)</title>
          <description>Viral kinetic assessment using SVR 12 to either &quot;lead-in&quot; 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment.</description>
          <population>See baseline characteristics</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Participants were assessed throughout their treatment intervention and through a 12 week followup period after completion of therapy, up to 60 weeks.</time_frame>
      <desc>Adverse events were only collected with regard to the affected organ system. Specific Adverse Event Terms are unknown.</desc>
      <group_list>
        <group group_id="E1">
          <title>Lead-In</title>
          <description>Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin</description>
        </group>
        <group group_id="E2">
          <title>No Lead-in</title>
          <description>No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>DAIDS</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>anemia</sub_title>
                <description>Not study drug related</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>DAIDS</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Blood and lymphatic system disorders</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiovascular disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General disorders</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskelatal disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous system disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric disorders</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Genitourinary disorders</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, thoracic, and mediastinal disorders</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin and sucutaneous-tissue disorders</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="2"/>
              </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>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kenneth E. Sherman, MD. PhD</name_or_title>
      <organization>University of Cincinnati</organization>
      <phone>513-558-3918</phone>
      <email>kenneth.sherman@uc.edu</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/NCT01704521
org study id: 12053004
secondary id: R34HL109334
nct id: NCT01704521
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
This study will examine viral dynamic responses in subjects with chronic hepatitis C and
      hemophilia when treated with pegylated interferon + ribavirin and telaprevir.
Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with
      hemophilia from participating.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Number of Participants With Sustained Virological Response at Week 12 (SVR12)
time frame: Post-treatment at week 12
description: Viral kinetic assessment using SVR 12 to either "lead-in" 4 weeks with PegInterferon + Ribavirin or no lead-in, followed by response guided therapy of 24 or 48 weeks based on viral response to treatment. Standard of care treatment stopping rules will be followed with assessment of viral response at week 12 of treatment.
arm group label: Lead-In
arm group type: Active Comparator
description: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
arm group label: No Lead-in
arm group type: Active Comparator
description: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegIntereron + Ribavirin
intervention type: Drug
intervention name: PegInterferon
arm group label: Lead-In
arm group label: No Lead-in
intervention type: Drug
intervention name: Ribavirin
arm group label: Lead-In
arm group label: No Lead-in
intervention type: Drug
intervention name: Telaprevir
arm group label: Lead-In
arm group label: No Lead-in
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kenneth E Sherman, MD, PhD
role: Principal Investigator
affiliation: University of Cincinnati
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: University of Cincinnati
investigator full name: Kenneth Sherman
investigator title: Kenneth E. Sherman, MD, PhD
mesh term: Hepatitis C
mesh term: Hepatitis C, Chronic
mesh term: Hepatitis
mesh term: Hemophilia A
mesh term: Ribavirin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 