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-GB
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-05
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

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

Inclusion Criteria

- Subject was previously randomized to the placebo group of a Phase II/III TMC435 study and did not achieve undetectable HCV RNA levels at the end of treatment or relapsed (confirmed detectable HCV RNA) within 1 year after end of treatment.
OR
Subject received short-term (up to 14 days) DAA treatment for HCV infection in a selected Tibotec-sponsored Phase I study on genotype 1;
- Subject must have completed the last study-related assessment in the previous study.

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

- Subject shows evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy);
- Subject has co-infection with nongenotype 1 HCV. Since all subjects have previously participated in a study evaluating subjects with genotype 1 HCV infection, this screening test is at the discretion of the investigator, to rule out nongenotype 1 HCV infection in case of clinical signs of acute hepatitis infection and suspicion of possible re-infection;
- Subject has co-infection with HIV type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at Screening);
- Subject has any of the following laboratory abnormalities at screening: platelet count = 90,000/mm3; absolute neutrophil count < 1500 cells/mm3 (blacks: < 1200 cells/mm3; hemoglobin < 12 g/dL for women and < 13 g/dL for men; creatinine >1.5 mg/dL; alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 10 x ULN; total serum bilirubin > 1.5 x ULN. Note: Retesting of an abnormal laboratory or urinalysis result that leads to exclusion will be allowed once using an unscheduled visit during the screening period to assess eligibility;
- Subject received any DAA HCV therapy, other than having received short-term (up to 14 days) DAA in a selected Tibotec-sponsored Phase I study;
- Subject prematurely stopped medication in the previous TMC435 study for noncompliance;
- Subject prematurely stopped medication in the previous TMC435 study for safety reasons, and it would therefore be unsafe to repeat treatment at investigator’s discretion.

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