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PROVE 1: Telaprevir + Peg-IFN + Ribavirin in Genotype 1 Hepatitis C
NCT00336479Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2006
- Primary completion
- Feb 2008
- Countries
- 2
- Sponsor
- Vertex Pharmaceuticals
- Modality
- Small Molecules
- Drugs
- telaprevir
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 2, randomised, double-blind trial of telaprevir in hepatitis C (HCV) (4 arms), sponsored by Vertex Pharmaceuticals. Primary endpoint: Sustained Virologic Response at Week 24. Started Jun 2006; status: completed.
02
Design
4 arms- Study design
- RandomizedDouble-blind
Control (PR48)
Placebo + Peg-IFN + RBV for 12 weeks, then Peg-IFN + RBV for 36 weeks (Total 48 weeks)
T12PR48
Telaprevir + Peg-IFN + RBV for 12 weeks, then Peg-IFN + RBV for 36 weeks (Total 48 weeks)
T12PR24
Telaprevir + Peg-IFN + RBV for 12 weeks, then Peg-IFN + RBV for 12 weeks (Total 24 weeks)
T12PR12
Telaprevir + Peg-IFN + RBV for 12 weeks (Total 12 weeks)
03
Who it enrols
Treatment-naïve patients with chronic genotype 1 hepatitis C virus infection, aged 18-65, without cirrhosis or other significant liver disease.
04
Endpoints
Primary
Sustained Virologic Response at Week 24
Secondary
Sustained Virologic Response at Week 12
Adverse Events and Serious Adverse Events
Viral Relapse
Plasma Concentration of Telaprevir
05
Results
Primary endpoints met
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