VX-950-TiDP24-C209: A Phase 2a Partially Blinded Clinical Study to Evaluate the Viral Kinetics and Safety of Telaprevir in Patients With Genotype 2 or 3 Infection.
The purpose of this study is to assess the effect of telaprevir on early HCV viral kinetics in treatment-naÃ-ve patients who are chronically infected with genotype 2 or 3 hepatitis C virus (HCV).
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-na�ve Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection.|
- This is an exploratory study. Viral kinetics, safety and pharmacokinetic/pharmacodynamic relationship will be studied.
|Study Start Date:||December 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
The purpose of this Phase IIa multicenter, partially blinded, randomized (study drug assigned by chance), stratified for genotype, multiple dose study is to assess the effect of telaprevir on HCV early viral kinetics in treatment-naïve patients who are chronically infected with genotype 2 or 3 hepatitis C virus (HCV).
The trial will consist of a screening period of approximately 4 weeks, a treatment period of 26 weeks, and a follow-up period of at least 24 weeks. The treatment period will be made up of a 2-week investigational treatment phase and a 24-week standard treatment phase.
A total of 48 patients who have never been treated for HCV (24 patients infected with HCV genotype 2 and 24 patients infected with HCV genotype 3) will be enrolled in the trial.
All patients will receive the investigational treatment regimen to which they have been randomized for 2 weeks. Subsequently, they will receive 24 weeks of standard treatment consisting of pegylated interferon (Peg-IFN) alfa2a 180 µg once-weekly and ribavirin (RBV) 400 mg twice per day.
Patients will be followed for at least 24 weeks after the end of treatment (EOT; Week 26 or early discontinuation) in order to assess sustained virologic response (SVR24) or to collect samples for viral sequencing.
HCV viral load quantification and safety/tolerability assessments will be performed frequently throughout the trial.
Extensive virologic and pharmacokinetic assessments for pharmacokinetic/pharmacodynamic analysis will be performed during the investigational treatment phase. There are 3 treatment groups in this study, each group will consist of 16 patients, 8 patients genotype 2 and 8 patients genotype 3. Group A. telaprevir 750 mg 3 times/day; B. telaprevir 750 mg 3 times/day + pegylated interferon alfa2a 180 µg once-weekly + ribavirin 400 mg twice per day; C. telaprevir placebo 3 times/day + pegylated interferon alfa2a 180 µg once-weekly + ribavirin 400 mg twice per day. This will be followed by 24 weeks of standard treatment with Peg-IFN and ribavirine.