VX-950-TiDP24-C210: A Study to Assess the Activity of Telaprevir on Hepatitis C Virus in Treatment Naive Patients Who Are Chronically Infected With Hepatitis C Genotype 4 Infection
The primary objective of the trial is to assess the activity of telaprevir on Hepatitis C Virus (HCV) genotype 4 replication by evaluating early viral kinetic parameters, when administered during 2 weeks, alone or in combination with pegylated interferon alfa2a and ribavirin. Secondary objectives are: to evaluate the single-dose and steady-state pharmacokinetics of telaprevir and the pharmacokinetic-pharmacodynamic relationship of telaprevir in patients chronically infected with HCV genotype 4; to evaluate the pharmacokinetics of Peg-IFN alfa2a and RBV alone and in combination with telaprevir; to assess and characterize phenotype and genotype resistant variants potentially arising after 2 weeks of telaprevir treatment (with or without Peg-IFN alfa2a and RBV), during the 48-week standard treatment phase, and during the 24-week follow-up phase, in patients chronically infected with HCV genotype 4; to evaluate the safety and tolerability of a 2-week treatment with telaprevir with or without Peg-IFN alfa2a and RBV in patients chronically infected with HCV genotype 4.
|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-naive Subjects With Chronic Genotype 4 Hepatitis C Infection.|
- This is an exploratory study. Viral kinetics, safety and pharmacokinetic/pharmacodynamic relationship will be studied.
|Study Start Date:||January 2008|
|Study Completion Date:||January 2010|
|Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
Approximately 3% of the global population are infected with Hepatitis C Virus (HCV). About 70% of the acute infections become persistent. The current standard of care for patients with HCV genotype 4 consists of a 48 week treatment with pegylated interferon combined with ribavirin.
This Phase IIa partially blinded, randomized (study drug assigned by chance), multiple dose trial aims to assess the activity of telaprevir on HCV- early viral kinetics in treatment-naïve patients who are chronically infected with HCV genotype 4.
The trial will consist of a screening period of maximum 6 weeks,a 2-week investigational treatment phase, a 46- or 48-week standard treatment phase, and a follow-up period of at least 24 weeks (maximum 48 weeks).
A total of 24 treatment-naïve HCV genotype 4-infected patients will be enrolled in the trial.
The patients will be randomized in a 1:1:1 ratio to1 of 3 investigational treatment groups:
A. telaprevir 750 mg every 8 hours (n=8) B. telaprevir 750 mg q 8h + pegylated interferon alfa2a (Peg-IFN alfa2a) 180 µg once-weekly + ribavirin (RBV) 1000-1200 mg/day (weight-based) (n=8) C. telaprevir placebo q 8h + Peg-IFN alfa2a 180 µg once-weekly + RBV 1000-1200 mg/day (weight-based) (n=8) All patients will receive the investigational treatment to which they have been randomized for 2 weeks. Subsequently, patients in Group A will receive 48 weeks of standard therapy (i.e., until Week 50), consisting of Peg-IFN alfa2a 180 µg once-weekly and RBV 1000-1200 mg/day (weight-based). Patients in Groups B and C will already receive standard therapy during the 2-week investigational treatment phase, and will continue standard therapy until they will have received 48 weeks of standard therapy.
After the end of treatment (EOT, i.e., either completed treatment or having discontinued all study medication earlier), all patients will be followed up for at least 24 weeks. If at any time during the follow-up period, a patient experiences relapse, he/she will not complete the planned follow-up visit schedule but instead will be asked to attend an additional visit 24 weeks after the relapse (i.e., visit 24 weeks after first detectability). HCV RNA 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: group A: telaprevir 750mg 3 times/day (oral), group B: telaprevir 750 mg 3 times/day (oral) + pegylated interferon alfa2a 180 µg once weekly (subcutaneous) + ribavirin 1000-1200mg/day (oral, weight based); group C: telaprevir placebo 3 times/day (oral) + pegylated interferon alfa2a 180 µg once weekly (subcutaneous)+ ribavirin 1000-1200mg/day (oral, weight based). Investigational treatment for two weeks and standard therapy 48 weeks in total.