Viral Kinetics in HCV Clearance in Subjects With Hemophilia

NCT ID: NCT01704521

Last Updated: 2015-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-10-31

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.

Detailed Description

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

Conditions

Chronic Hepatitis C; Hemophilia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

PegInterferon

Intervention Type: DRUG

Ribavirin

Intervention Type: DRUG

Telaprevir

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

PegInterferon

Intervention Type: DRUG

Ribavirin

Intervention Type: DRUG

Telaprevir

Intervention Type: DRUG

Interventions

PegInterferon

Intervention Type: DRUG

Ribavirin

Intervention Type: DRUG

Telaprevir

Intervention Type: DRUG

Eligibility 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

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.

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Kenneth Sherman

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Sherman

Kenneth E. Sherman, MD, PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Kenneth E Sherman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

UC Physicians Company

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

R34HL109334

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12053004

Identifier Type: -

Identifier Source: org_study_id