Clinical trial NCT01290731: A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic
Hepatitis C virus
Interferon Alfa-2a
Ribavirin
Viral RNA
Lead sponsor: Janssen Pharmaceutical K.K.
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12)
timeFrame: Week 36 or 60
Secondary outcomes:
measure: The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24)
timeFrame: Week 48 or 60
measure: 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
timeFrame: Days 3 and 7, Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 36, 48, 60, 72, EOT, and follow-up (FU) Weeks 4, 12, and 24
measure: The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT)
timeFrame: Weeks 4, 12, 24, 36, 48, 60, 72, and at EOT
measure: The Number of Participants With Viral Breakthrough
timeFrame: Day 1 until end of treatment (EOT [Week 24 or 48])
measure: The Number of Participants Demonstrating Viral Relapse
timeFrame: Up to 72 weeks
measure: Plasma Concentrations of TMC435
timeFrame: Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)
measure: Area Under the Plasma Concentration-time Curve From 0 to 24 Hrs (AUC24h) for TMC435
timeFrame: Overall (blood sampling times were 3 and 5 hours post- dose at Week 2 and Week 8 and pre-dose and 2 hours post-dose at Week 4 and Week 12)
measure: The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT)
timeFrame: EOT (Week 24 or 48)
Other outcomes:
Locations:
city: Hiroshima
country: Japan
city: Ichikawa
country: Japan
city: Kagoshima
country: Japan
city: Matsumoto
country: Japan
city: Musashino
country: Japan
city: Ohmura
country: Japan
city: Osaka
country: Japan
city: Sapporo
country: Japan
city: Suita
country: Japan
city: Touon
country: Japan
Study officials:
affiliation: Janssen Pharmaceutical K.K.
name: Janssen Pharmaceutical K.K. Clinical Trial
role: STUDY_DIRECTOR
References: