NCT00627926

A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,095 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Conditions

• Hepatitis C

Interventions

Type	Name	Description
BIOLOGICAL	Pegylated Interferon Alfa 2a	subcutaneous injection, 180 micrograms once per week
DRUG	Telaprevir	375 mg tablets administered orally every 8 hours at a dose of 750 mg
DRUG	Ribavirin	200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing ≥75 kg
OTHER	Placebo	Telaprevir matching placebo

Timeline

• Start date: 2008-03-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2008-03-04
• Last updated: 2014-08-08
• Results posted: 2011-07-21

Locations

116 sites across 13 countries: United States, Argentina, Australia, Austria, Canada, France, Germany, Israel, Italy, Poland, Puerto Rico, Spain, United Kingdom