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Prospective, Single-Center, Open Label, Pilot Study of Safety and Efficacy of Triple Anti-Viral Therapy With Pegylated Interferon, Ribavirin, and Boceprevir in Patients With Genotype 1 Chronic HCV With End Stage Renal Disease
The purpose of the study is to assess the safety and efficacy of triple therapy with pegylated interferon (P-IFN), ribavirin and boceprevir in patients with genotype 1 chronic Hepatitis C Virus (HCV) infection and end stage renal disease (ESRD) on hemodialysis (HD).
Details
| Lead sponsor | Columbia University |
|---|---|
| Phase | NA |
| Status | WITHDRAWN |
| Start date | 2013-05 |
| Completion | 2015-02 |
Conditions
- Hepatitis C Infection
- End Stage Renal Disease
Interventions
- P-IFN alfa 2a
- P-IFN alfa 2b
- Ribavirin
- Boceprevir
Primary outcomes
- Proportion of patients who achieve sustained virologic response — Up to 12 weeks after discontinuation of all therapy
Primary efficacy is the proportion of patients who achieve sustained virologic response at week 12 after discontinuation of all therapy (SVR12).