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A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection

NCT00561015 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2013-06-17

Study results available
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Summary

The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

Telaprevir

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

DRUG

Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)

Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.

DRUG

Placebo

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

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
2007-12-31
Primary Completion
2008-06-30
Completion
2009-05-31

Countries

  • France
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT00561015 on ClinicalTrials.gov