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

PHASE2CompletedINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

December 31, 2007

Primary Completion Date

June 30, 2008

Study Completion Date

May 31, 2009

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.

Trial Locations (7)

Unknown

Clichy

Créteil

Lyon

Paris

Vandœuvre-lès-Nancy

Stockholm

London

All Listed Sponsors
lead

Tibotec BVBA

INDUSTRY

NCT00561015 - A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection | Biotech Hunter | Biotech Hunter