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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Vertex Pharmaceuticals Incorporated
Genentech
Information provided by (Responsible Party):
Kenneth Sherman, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01704521
First received: October 5, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

This study will examine treatment response in subjects with chronic hepatitis C and hemophilia with pegylated interferon + ribavirin and telaprevir.


Condition Intervention Phase
Hepatitis C With Hemophilia
Other: Lead -In- PegInterferon + Ribavirin (4 weeks); PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon + Ribavirin (8 weeks)
Other: No Lead-in - No 4-week lead in therapy; PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon+ Ribavirin (12 weeks)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Viral Kinetic Models of HCV Clearance in Hemophiliacs With Telaprevir

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Viral Kinetic Models of HCV Clearance in Hemophiliacs with Telaprevir [ Time Frame: Viral kinetics at Week 12 ] [ Designated as safety issue: Yes ]
    Subjects will be randomized 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.


Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lead -In
Response Guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by 8 weeks of PegInterferon + Ribavirin.
Other: Lead -In- PegInterferon + Ribavirin (4 weeks); PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon + Ribavirin (8 weeks) Other: No Lead-in - No 4-week lead in therapy; PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon+ Ribavirin (12 weeks)
Active Comparator: No Lead -in
Response Guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by 12 weeks of PegInterferon + Ribavirin
Other: Lead -In- PegInterferon + Ribavirin (4 weeks); PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon + Ribavirin (8 weeks) Other: No Lead-in - No 4-week lead in therapy; PegInterferon + Ribavirin + Telaprevir (12 weeks); PegInterferon+ Ribavirin (12 weeks)

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01704521

Locations
United States, Ohio
Cincinnati, Ohio, United States, 45267
Sponsors and Collaborators
Kenneth Sherman
Vertex Pharmaceuticals Incorporated
Genentech
Investigators
Principal Investigator: Kenneth E Sherman, MD, PhD University of Cincinnati
  More Information

No publications provided

Responsible Party: Kenneth Sherman, Kenneth E. Sherman, MD, PhD, University of Cincinnati
ClinicalTrials.gov Identifier: NCT01704521     History of Changes
Other Study ID Numbers: 12053004, R34HL109334
Study First Received: October 5, 2012
Last Updated: April 22, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Cincinnati:
Hepatitis C
HCV
Hemophilia

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014