A Phase III, Open-Label, Single Arm Trial of TMC435 in Combination With Peginterferon Alpha-2A and Ribavirin for HCV Genotype-1 Infected Subjects Who Participated in the Placebo Group of a Phase II/III TMC435 Study, or Who Received DAA Treatment in a Tibotec-Sponsored Phase I Study.

• Conditions: Hepatitis C Virus (HCV) genotype-1 infection; MedDRA version: 14.1Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-000416-25-BE
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-01
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 326

Inclusion Criteria

- Patients who participated in the placebo arm of a TMC435 study who did not achieve undetectable HCV RNA levels at end of treatment or who relapsed within 1 year after end of treatment OR Patients who received short-term direct-acting antiviral therapy in a Tibotec-sponsored study.
- Liver disease stage documented by liver biopsy is required within 3 years prior to screening unless contraindicated.

Please refer to the protocol for the complete list of inclusion criteria.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 318
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

- Infection with human immunodeficiency virus. - Liver disease not related to hepatitic C infection.
- Significant laboratory abnormalities or other active diseases.
- Pregnant or planning to become pregnant.
- Prematurely stopped medication in previous TMC435 study for noncompliance or for safety reasons.

Please refer to the protocol for the complete list of exclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified