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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01290731
First received: February 3, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Hepatitis C, Chronic
 Drug: TMC435
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase III, Open-label Trial in Japan to Investigate the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Genotype 1, Hepatitis C-infected Subjects Who Relapsed After Previous IFN-based Therapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Proportion of patients with sustained virological response (SVR24) [ Time Frame: Follow-up Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma concentrations of TMC435 [ Time Frame: Up to 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with sustained virological response (SVR12) [ Time Frame: Follow-up Week 12 ] [ Designated as safety issue: No ]
  • Proportion of patients with 2 log 10 IU/mL or more decrease in HCV RNA [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with undetectable HCV RNA [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients with viral breakthrough [ Time Frame: Up to 48 weeks ] [ Designated as safety issue: No ]
  • Proportion of patients showing viral relapse [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: Up to 72 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
TMC435 100-mg capsule once daily for 12 weeks
 Drug: TMC435
100-mg capsule once daily for 12 weeks

Detailed Description:

This is a single-arm study to evaluate the efficacy and safety of TMC435 in combination with the standard of care (SoC), pegIFN alfa-2a and ribavirin, in adult, genotype 1 HCV-infected patients who relapsed after previous IFN-based therapy in Japan. The study objective is to evaluate the efficacy of TMC435 by the proportion of the patients with undetectable HCV ribonucleic acid (RNA). Patients will receive 12 weeks of treatment with TMC435 (100 mg) once daily plus SoC followed by 12 or 36 weeks of treatment with SoC. TMC435 is a 100-mg capsule and will be taken orally (via the mouth). The SoC treatment will last 24 or 48 weeks. Pegylated interferon is supplied as a vial containing 1.0 mL solution with 180 µg pegIFN alpha-2a. It 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 patients will receive oral capsules of TMC435 (100 mg) once daily up to Week 12.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient must have chronic genotype 1 HCV with HCV RNA level >= 5.0 log10 IU/mL
  • Patient relapsed after previous IFN-based therapy
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01290731

Locations
Japan
Hiroshima, Japan
Ichikawa, Japan
Kagoshima, Japan
Matsumoto, Japan
Musashino, Japan
Nagasaki, Japan
Ohmura, Japan
Osaka, Japan
Sapporo, Japan
Suita, Japan
Suita N/A, Japan
Touon, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K. Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01290731     History of Changes
Other Study ID Numbers: CR017698, TMC435HPC3008
Study First Received: February 3, 2011
Last Updated: May 2, 2013
Health Authority: Japan: Japan Pharmaceuticals And Medical Devices Evaluation Center
Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Hepatitis C
Hepatitis C virus
Interferon Alfa-2a
Ribavirin
Viral RNA

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Interferons
Peginterferon alfa-2a
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 23, 2013