Phase 3
Completed N=10
Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment
Source: ClinicalTrials.gov NCT01585584 ↗Enrolled (actual)
10
Serious AEs
20.0%
Results posted
Sep 2015
Primary outcomePrimary: Sustained Virologic Response (SVR) at 24 Weeks Post Treatment — 6; 3 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sustained Virologic Response (SVR) at 24 Weeks Post Treatment |
6; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects will be eligible for the study if they meet the following inclusion criteria:
- 18 years of age or older
- Infected with HCV genotype 3 (mixed genotypes are NOT permitted)
- Have received at least 12 weeks of previous treatment with peginterferon-α + ribavirin
- Detectable serum HCV-RNA
- No significant co-morbid conditions
- Liver biopsy is not necessary
- 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:
- Significant comorbidities: uncontrolled psychiatric conditions including severe depression, cardiovascular, respiratory, renal or metabolic conditions, active carcinoma.
- Active substance abuse within the past 12 months
- Co-infection with hepatitis B or HIV
- Decompensated cirrhosis (Child-Pugh class B or C)
- 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
- Lack of informed consent
- Previous null-responders (<2 log10 decrease at week 12 with previous PR therapy)
Data sourced from ClinicalTrials.gov (NCT01585584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.