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An Exploratory Study of Telaprevir in Treatment-Naive Participants With Chronic Genotype 4 Hepatitis C Virus Infection

NCT00580801 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-09-09

Study results available
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Summary

The purpose of this study is to evaluate the activity and safety of telaprevir on Hepatitis C Virus (HCV) Genotype 4, alone or in combination with standard therapy, that is, pegylated-interferon-alfa-2a and ribavirin in treatment-naive (never been treated before with antiretroviral therapy) participants.

Conditions

  • Hepatitis C

Interventions

DRUG

Telaprevir

Telaprevir 750 milligram (mg) tablet will be administered three times a day orally for 2 weeks.

DRUG

Pegylated-interferon-alfa-2a

Pegylated-interferon-alfa-2a (180 microgram \[mcg\] subcutaneous injection, once weekly) will be administered from Week 1 to Week 48 or 50.

DRUG

Placebo

Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks.

DRUG

Ribavirin

Ribavirin (1000-1200 mg as oral tablet daily) will be administered from Week 1 to Week 48 or 50.

Sponsors & Collaborators

  • Tibotec BVBA

    lead INDUSTRY

Principal Investigators

  • Tibotec-Virco Virology BVBA Clinical Trial · Tibotec BVBA

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-01-31
Completion
2010-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00580801 on ClinicalTrials.gov