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A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection

Information source: Janssen Pharmaceutical K.K.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis C, Chronic

Intervention: TMC435 (Drug); Peginterferon alfa-2b (pegIFN alfa-2b) (Drug); Ribavirin (RBV) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Janssen Pharmaceutical K.K.

Official(s) and/or principal investigator(s):
Janssen Pharmaceutical K.K. Clinical Trial, Study Director, Affiliation: Janssen Pharmaceutical K.K.

Summary

The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis C virus (HCV)-infected participants who are treatment-naive or treatment-experienced (prior relapser or non-responder to Interferon-based therapy) in Japan.

Clinical Details

Official title: A Phase III, Open-Label Study in Japan to Assess the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2b and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)

The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)

The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During Treatment and at the End of Treatment

The Number of Participants With Viral Breakthrough

The Number of Participants Demonstrating Viral Relapse

The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at the End of Treatment (EOT)

The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up

The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2b (PegIFN╬▒-2b) and Ribavirin (RBV) at Week 24

The Area Under the Plasma Concentration-Time Curve (From 0 to 24 Hours) (AUC24h)

Plasma Concentrations of TMC435

Detailed description: This is an open-label study (all people involved know the identity of the intervention) to evaluate the efficacy and safety of TMC435 (also referred to as jnj-38733214-aaa) in combination with the standard of care therapy (SoC: peginterferon [pegIFN] alfa-2b and ribavirin) in adult, genotype 1 hepatitis C virus (HCV)-infected participants who are treatment-naive (never received treatment for HCV), prior relapsers (relapsed after previous interferon [IFN]-based therapy), or non-responders (failed to respond to previous IFN-based therapy) in Japan. The study objective is to evaluate the efficacy, safety, and pharmacokinetics of TMC435. A sufficient number of participants who are treatment-naive, prior relapsers to treatment with IFN-based therapy, and prior non-responders to treatment with IFN-based therapy will be enrolled and assigned to 1 of 3 panels (referred to as treatment groups). Participants who are treatment-naive or prior relapsers to IFN-based therapy will receive 12 weeks of treatment with TMC435 (100 mg) once daily with pegIFN alfa-2b and ribavirin (PR) followed by an additional 12 or 24 weeks of treatment with PR. Participants who are non-responders to IFN-based therapy will receive 12 weeks of treatment with TMC435 (100 mg) once daily with PR followed by an additional 36 weeks of treatment with PR. TMC435 is a 100-mg capsule and will be taken orally by mouth. The SoC treatment will consist of Pegylated interferon (PegIFN alpha-2b) (1. 5 mcg/kg) injected with a syringe subcutaneously (under the skin) once weekly and ribavirin 200-mg capsules (daily dose: 600-1000 mg based on body weight) taken orally by mouth 2 times a day after meals for 24 or 48 weeks.

Eligibility

Minimum age: 20 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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 (treatment-naive), relapsed after

previous IFN-based therapy (prior relapser) or failed to respond to previous IFN-based therapy (non-responder)

- 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 peg-IFN or ribavirin therapy

- History of, or any current medical condition, which could impact the safety of the

patient in the study

Locations and Contacts

Amagasaki, Japan

Ikeda, Japan

Kawasaki, Japan

Kumamoto, Japan

Niigata, Japan

Ohmura, Japan

Osaka, Japan

Sakai, Japan

Sapporo, Japan

Suita, Japan

Tokyo, Japan

Additional Information

Starting date: May 2011
Last updated: April 10, 2014

Page last updated: August 23, 2015

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