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Viral Kinetics in HCV Clearance in Subjects With Hemophilia (HCV/Hemophil)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01704521
Recruitment Status : Completed
First Posted : October 11, 2012
Results First Posted : April 6, 2015
Last Update Posted : April 6, 2015
National Heart, Lung, and Blood Institute (NHLBI)
Vertex Pharmaceuticals Incorporated
Genentech, Inc.
Information provided by (Responsible Party):
Kenneth Sherman, University of Cincinnati

Brief Summary:
This study will examine viral dynamic responses in subjects with chronic hepatitis C and hemophilia when treated with pegylated interferon + ribavirin and telaprevir.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Hemophilia Drug: PegInterferon Drug: Ribavirin Drug: Telaprevir Phase 1

Detailed Description:
Previous clinical trials for treatment of chronic hepatitis C have excluded subjects with hemophilia from participating.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Viral Kinetic Models of HCV Clearance in Hemophiliacs With Telaprevir
Study Start Date : December 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ribavirin

Arm Intervention/treatment
Active Comparator: Lead-In
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
Drug: PegInterferon
Drug: Ribavirin
Drug: Telaprevir
Active Comparator: No Lead-in
Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegIntereron + Ribavirin
Drug: PegInterferon
Drug: Ribavirin
Drug: Telaprevir

Primary Outcome Measures :
  1. Number of Participants With Sustained Virological Response at Week 12 (SVR12) [ Time Frame: Post-treatment at week 12 ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Hemophilia A or B
  2. HCV RNA positive (PCR or branched-chain DNA Methods), Genotype 1 (a/b, mixed and unknown subtype)
  3. Chronic HCV infection evidenced by HCV serology, HCV RNA or liver enzyme abnormalities present at least 6 months prior to enrollment
  4. Liver biopsy or non-invasive marker that permits fibrosis staging within 12 months of enrollment. If a biopsy was not performed within 1 year, non-invasive markers may be utilized during screening period. Cirrhosis is not an exclusion factor
  5. Age ≥ 18 years
  6. Prior HCV treatment naïve or experienced
  7. HCV viral load detectable during screening period
  8. Absence of exclusion criteria
  9. Sexually active subjects (both male and female) must agree and commit to the use of a medically acceptable form of contraception for the duration of the study and for 6 months following the last dose of study medication. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices or properly used barrier contraception.

Exclusion Criteria:

  1. Hemoglobin <11
  2. Pregnancy (during screening period or any time during treatment)

    1. females, that are planning to become pregnant or are breastfeeding
    2. males, whose partner is pregnant or is planning to become pregnant
  3. HIV Infection
  4. Prior History of:

    1. Hepatitis B (HBsAG negative - must have documentation of negative results within one year prior to enrollment or during screening period if not performed in that time window
    2. Homozygotic alpha-1-anti-trypsin (a1AT) deficiency - documentation of a1AT level <80 (at anytime prior to screening). If <80, phenotype testing should not demonstrate zz phenotype. All other phenotypes are not exclusionary,
    3. History of Homozygotic Genetic Hemochromatosis (at anytime prior to enrollment) with evidence of iron overload requiring phlebotomy,
    4. Autoimmune markers (antinuclear antibody (ANA) and/or antismooth muscle antibody (ASMA)) >1:160.
    5. Any other significant liver disease or process (to be determined by the investigator). Non-alcoholic fatty-liver disease (NAFLD) is not an exclusion.
  5. History of Decompensated liver disease evidenced by any prior history of hepatic encephalopathy (Grade 2 or higher), ascites, variceal bleeding; Platelet count < 100,000
  6. Active thyroid disease (OK if on thyroid replacement with normal thyroid-stimulating hormone (TSH); if TSH abnormal must have normal free thyroid index)
  7. Chronic renal insufficiency, defined as creatinine clearance < 50 ml/min. (estimated by Modification of Diet in Renal Disease (MDRD) formula)
  8. Life-threatening disease processes that could preclude completion of trial in opinion of investigator.
  9. Any condition which the investigator feels will preclude safe completion of the treatment regimen including severe psychiatric disorders, active alcohol or recreational drug abuse.
  10. Inability to provide informed consent.
  11. Use of systemic corticosteroids or immunomodulatory drugs within 1 month (Nasal steroids are permitted.)
  12. Uncontrolled seizure disorder (in opinion of investigator)
  13. Concurrent autoimmune processes with active disease that may be exacerbated by interferon-based therapies (e.g. Crohn's Disease, Rheumatoid arthritis) in the opinion of the investigator. Psoriasis permitted if controlled with topical medications at the time of study enrollment.
  14. Use of prohibited medications (as described in the telaprevir package insert) within 14 days of the first dose of study medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01704521

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United States, Ohio
UC Physicians Company
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Kenneth Sherman
National Heart, Lung, and Blood Institute (NHLBI)
Vertex Pharmaceuticals Incorporated
Genentech, Inc.
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Principal Investigator: Kenneth E Sherman, MD, PhD University of Cincinnati
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Responsible Party: Kenneth Sherman, Kenneth E. Sherman, MD, PhD, University of Cincinnati Identifier: NCT01704521    
Other Study ID Numbers: 12053004
R34HL109334 ( U.S. NIH Grant/Contract )
First Posted: October 11, 2012    Key Record Dates
Results First Posted: April 6, 2015
Last Update Posted: April 6, 2015
Last Verified: March 2015
Keywords provided by Kenneth Sherman, University of Cincinnati:
Hepatitis C
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hemophilia A
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents