Clinical trial NCT00528528
Conditions: Chronic Hepatitis C
Keywords: Chronic Hepatitis C Genotype 1 Telaprevir Treatment-naïve VX-950-C208 VX-950-TiDP24-C208
Sponsor: Tibotec BVBA
Start date: 2007-10-01; Completion date: 2009-08-01
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. arm 2: Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks. arm 3: Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks. arm 4: Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
Interventions: intervention 1: Telaprevir intervention 2: Peg-IFN-alfa-2a intervention 3: Peg-IFN-alfa-2b intervention 4: Ribavirin (RBV) tablet intervention 5: Ribavirin (RBV) capsule
Intervention descriptions: intervention 1: Oval tablets containing 375 mg of telaprevir for oral administration. intervention 2: Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe. intervention 3: Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen. intervention 4: Tablets containing 200 mg RBV for oral administration. intervention 5: Capsules containing 200 mg RBV for oral administration.

Protocol documents: