A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Hepatitis C, Chronic

Treatments: Drug: Peginterferon alfa-2a (pegIFN alfa-2a); Drug: Ribavirin (RBV); Drug: TMC435; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01292239

CR017686

TMC435HPC3003 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection in Japan.

Full description

This is a randomized (study drug assigned by chance), 2-arm, double-blind study to evaluate the efficacy and safety of TMC435 (also referred to as jnj-38733214-aaa) versus placebo in combination with the standard of care (SoC) therapy (peginterferon alfa-2a [pegIFN alfa-2a] and ribavirin) in adult treatment-naïve patients (who never received treatment for HCV) with chronic genotype 1 HCV infection in Japan. The study objective is to evaluate and compare the efficacy of TMC435 vs placebo by the proportion of the patients with undetectable HCV ribonucleic acid (RNA). In the TMC435 treatment group, patients will receive 12 weeks of treatment with TMC435 (100 mg) once daily plus SoC followed by an additional 12 or 36 weeks of treatment with SoC. In the placebo treatment group, patients will receive 12 weeks of treatment with placebo once daily plus SoC followed by an additional 36 weeks of treatment with SoC. TMC435 is a 100-mg capsule and will be taken orally by mouth. The SoC treatment will be given for 24 or 48 weeks. Pegylated interferon is supplied as a vial containing 1.0 mL solution with 180 mcg pegIFN alpha-2a and administered subcutaneously (injected by a syringe under the skin) once weekly. Ribavirin is given as 200-mg tablets (daily dose: 600-1000 mg based on body weight), and taken orally by mouth two times a day after meals.

Enrollment: 183 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient must have chronic genotype 1 HCV infection with HCV RNA level >= 5.0 log10 IU/mL
• Patient has never received treatment for HCV
• Patient 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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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183 participants in 2 patient groups

TMC435 100 mg 12 Wks + PR 24/48

Experimental group

Description:

Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 for participants who achieved HCV RNA \< 1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.

Treatment:

Drug: Ribavirin (RBV)

Drug: Peginterferon alfa-2a (pegIFN alfa-2a)

Drug: TMC435

PBO 12 Wks + PR 48

Experimental group

Description:

Participants received placebo (PBO) once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.

Treatment:

Drug: Ribavirin (RBV)

Drug: Placebo

Drug: Peginterferon alfa-2a (pegIFN alfa-2a)