A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tibotec Pharmaceuticals, Ireland
• Treatments: Interferon alpha-2; Interferon-alpha; Peginterferon alfa-2a; Ribavirin; Simeprevir

Criteria

Inclusion Criteria:

• Must have chronic hepatitis C infection as evidenced by liver biopsy, anti-hepatitis C virus (HCV) and HCV RNA positive

• Must have chronic hepatitis C infection (genotype 1) with HCV RNA level greater than10000 IU/mL

• Patient must have failed at least 1 prior course of peg interferon (Peg-IFN-alfa-2a)/ribavirin (RBV) therapy (standard treatment)

• Must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion Criteria:

• Has an evidence of decompensated liver disease

• Co-infection with any other Hepatitis C virus genotype or co-infection with the human immunodeficiency virus (HIV)

• Has a medical condition which is a contraindication to Peg-INF or RBV therapy

• Have had history of, or any current medical condition which could impact the safety of the patient in the study