drugset / Trial / NCT01498068

Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C

NCT01498068

Phase 3 Completed 36 enrolled Janssen-Cilag International NV
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced Russian participants with genotype 1 chronic hepatitis C.

Timeline

Start
2012-01
Primary completion
2012-04
Completion
2013-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Telaprevir Small molecule 750 mg Oral
Background Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 1000 mg Oral
Background Ribavirin Small molecule 1200 mg Oral