Overview

Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment

Status:
Completed

Trial end date:
2015-07-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to test the potential antiviral efficacy of triple-combination therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype 3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Calgary

Collaborator:

Merck Sharp & Dohme Corp.

Treatments:

Protease Inhibitors
Ribavirin

Criteria

Inclusion Criteria:

- Subjects will be eligible for the study if they meet the following inclusion criteria:

1. 18 years of age or older

2. Infected with HCV genotype 3 (mixed genotypes are NOT permitted)

3. Have received at least 12 weeks of previous treatment with peginterferon-α +
ribavirin

4. Detectable serum HCV-RNA

5. No significant co-morbid conditions

6. Liver biopsy is not necessary

7. Cirrhotic patients will be eligible to participate if Child-Pugh class A (maximum
15% of subjects)

Exclusion Criteria:

- Subjects will be excluded from participation in this study if the following conditions
are present:

1. Significant comorbidities: uncontrolled psychiatric conditions including severe
depression, cardiovascular, respiratory, renal or metabolic conditions, active
carcinoma.

2. Active substance abuse within the past 12 months

3. Co-infection with hepatitis B or HIV

4. Decompensated cirrhosis (Child-Pugh class B or C)

5. Significant cytopenia - any of the following: platelets <80 x 109/L, neutropenia
<1.2 x 103/L, Hb <120 g/l for men or 110 g/l for women

6. Lack of informed consent

7. Previous null-responders (<2 log10 decrease at week 12 with previous PR therapy)