An Open-Label, Single-Arm Phase III Study to Evaluate the Efficacy, Safety and Tolerability of TMC435 in Combination With PegIFN alfa-2a (Pegasys) and Ribavirin (Copegus) in Treatment-Naïve or Treatment-Experienced, Chronic Hepatitis C Virus Genotype-4 Infected Patients

Phase 1

• Conditions: Hepatitis C Virus genotype-4 (HCV-4) in treatment-naïve or treatment-experienced subjects; MedDRA version: 14.1Level: LLTClassification code 10019752Term: Hepatitis C virus (HCV)System Organ Class: 10022891 - Investigations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-004097-29-BE
• Lead Sponsor: Janssen R&D Ireland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-21
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Genotype 4 Hepatitis C virus (HCV) infection (confirmed at screening)
- Plasma HCV ribonucleic acid (RNA) of > 10,000 IU/mL at screening
- Participants should be either treatmentnaïve or treatment-experienced (non-responder or relapser) with adequate documentation of previous response
- Participants must have voluntarily signed an Informed Consent Form (ICF) indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. To participate in the optional pharmacogenomic component in this study (exploratory host genotyping), participants must have voluntarily signed a separate ICF for this component (where local regulations permit). Refusal to give consent for this component does not exclude a participant from participation in the core study.
- A liver biopsy is required within 3 years prior to screening unless the patient has a contraindication for a liver biopsy.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 98
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

- Has an infection/co-infection with non-genotype 4 HCV
- Has a co-infection with Human Immunodeficiency Virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening).
- Has any of the following laboratory abnormalities: a. Platelet count < 90,000/mm3 (blacks: < 75 000 cells/mm3); b. Absolute neutrophil count (ANC) < 1500 cells/mm3 (Blacks: < 1000 cells/mm3); c. Hemoglobin < 12 g/dL for women and < 13 g/dL for men; d. Creatinine > 1.5 mg/dL; e. ALT and/or AST > 10 x upper limit of normal (ULN); f. Total serum bilirubin > 1.5 x ULN; g. Alpha-fetoprotein [AFP] > 50 ng/mL; h. Albumin serum concentration < 3.5 g/dL; i. Prothrombin time (PT) expressed as international normalized ratio (INR) > 1.5.
- Uses disallowed concomitant therapy
- Has evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective is to evaluate the efficacy of TMC435 in combination with PegIFNa-2a/RBV with respect to the proportion of subjects with chronic HCV-4 infection achieving SVR 12 weeks after planned end of treatment (SVR12) in the overall population as well as in the different subpopulations (treatment-naïve, previous relapsers and previous nonresponders).;Secondary Objective: See section 2.1, page 31 and 32 of the Protocol;Primary end point(s): Efficacy of TMC435 with respect to proportion of participants achieving SVR12;Timepoint(s) of evaluation of this end point: week 36 or week 60, depending on when the patients can stop treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Efficacy of TMC435 with respect to proportion of participants achieving SVR24<br>- Antiviral activity of TMC435 in combination with PegIFNa-2a/RBV<br>- on-treatment virologic failure;Timepoint(s) of evaluation of this end point: - week 48 or week 72, depending on when the patients can stop treatment<br>- at all timepoints during treatment and follow-up<br>- Week 4, Week 12, Week 24, Week 36, Week 48<br>- all visits