NCT00528528

An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

A Phase IIa Randomized, Open-Label Study of Telaprevir (VX-950) Administered Every 12 or Every 8 Hours in Combination With Either Peg-IFN alfa2a (Pegasys) and Ribavirin (Copegus) or Peg-IFN alfa2b (PegIntron) and Ribavirin (Rebetol) in Treatment-Naive Subjects With Chronic Genotype 1 Hepatitis C Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 166 (actual)
• Sponsor: Tibotec BVBA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

Detailed description

This is a Phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' individual virologic response, and a follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and participants will continue on standard therapy only. Participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir (750 milligram \[mg\] every 8 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated interferon \[Peg-IFN\]-alfa-2a and ribavirin \[RBV\] or Peg-IFN-alfa-2b and RBV at the standard doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response, viral breakthrough, partial response, early viral kinetics and sustained viral response. Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety will be monitored throughout the study duration.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Telaprevir	Oval tablets containing 375 mg of telaprevir for oral administration.
DRUG	Peg-IFN-alfa-2a	Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.
DRUG	Peg-IFN-alfa-2b	Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.
DRUG	Ribavirin (RBV) tablet	Tablets containing 200 mg RBV for oral administration.
DRUG	Ribavirin (RBV) capsule	Capsules containing 200 mg RBV for oral administration.

Timeline

• Start date: 2007-10-01
• Primary completion: 2009-07-01
• Completion: 2009-08-01
• First posted: 2007-09-12
• Last updated: 2014-06-25
• Results posted: 2013-05-01

Locations

24 sites across 6 countries: Austria, Belgium, France, Germany, Netherlands, Spain