A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: Pegylated interferon (pegIFN alpha-2a); Drug: TMC435; Drug: Ribavirin (RBV)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01290731

TMC435HPC3008 (Other Identifier)

CR017698

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in Japan.

Full description

This is a single-arm study to evaluate the efficacy and safety of TMC435 in combination with the standard of care (SoC), PegIFNα-2a (P) and ribavirin (R), in adult, genotype 1 HCV-infected participants who relapsed after previous IFN-based therapy in Japan. The study objective is to evaluate the efficacy of TMC435 by the percentage of participants with undetectable HCV ribonucleic acid (RNA). Participants will receive 12 weeks of treatment with TMC435 (100 mg) once daily plus PR followed by 12 or 36 weeks of treatment with PR. TMC435 is a 100-mg capsule and will be taken orally (via the mouth). Treatment with PR will last 24 or 48 weeks. Pegylated interferon is supplied as a vial containing 1.0 mL solution with 180 µg PegIFNα-2a and will be injected by a syringe under the skin once weekly. Ribavirin is given as 200-mg tablets (daily dose: 600-1000 mg), taken orally two times a day after meals. The participants will receive oral capsules of TMC435 (100 mg) once daily up to Week 12.

Enrollment: 49 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have chronic genotype 1 HCV with HCV RNA level >= 5.0 log10 IU/mL
• Participant relapsed after previous IFN-based therapy
• Participant must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication.

Exclusion criteria

• Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV)
• Diagnosed with hepatic cirrhosis or hepatic failure
• A medical condition which is a contraindication to pegIFN or ribavirin therapy
• History of, or any current medical condition, which could impact the safety of the patient in the study

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

TMC435 100 mg 12 Wks + PR24/48

Experimental group

Description:

Participants will receive TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment will be stopped at Week 24 in participants who achieve plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels less than (\<) 1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants will continue PR until Week 48 (PR 48).

Treatment:

Drug: Ribavirin (RBV)

Drug: TMC435

Drug: Pegylated interferon (pegIFN alpha-2a)