TMC435-TiDP16-C216 - Phase III Trial of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients (QUEST-2)
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who have never received treatment before. Patients will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.
Janssen R&D Ireland has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Phase III, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon a-2a and Ribavirin or Peginterferon a-2b and Ribavirin in Treatment-naive, Genotype 1 Hepatitis C-infected Subjects|
- The proportion of patients with sustained viral response (SVR) 24 weeks after the planned end of treatment [ Time Frame: 24 weeks after planned end of treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
TMC435 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 24 or 48 weeks
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 24 or 48 weeks
Placebo Comparator: 002
Placebo 150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 48 weeks
150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 48 weeks
This is a randomized, double-blind (neither physician or patients knows the name of the assigned drug), placebo-controlled study of TMC435 in patients who are infected with genotype 1 hepatitis C virus who have never received treatment for this before. Patients in this study will also receive two other drugs for their infection (either peginterferon alfa-2a (Pegasys®) and ribavirin (Copegus®) or peginterferon alfa-2b (PegIntron®) and ribavirin (Rebetol®). The purpose of the study is to investigate if TMC435 is superior to placebo in reducing hepatitis C virus to an undetectable level 24 weeks after the end of treatment. For the first 12 weeks, patients will take either TMC435 or placebo, plus peginterferon and ribavirin. For the next 12 weeks, patients will take peginterferon and ribavirin only. After that, some patients will continue to take peginterferon and ribavirin for up to 24 additional weeks. Other patients will stop taking peginterferon and ribavirin. The study doctor will inform each patient about how to take their study medication and when they should stop taking it. After a patient stops taking study medication, they will continue to come to the doctor's office for study visits until a total of 72 weeks after they enroll in the study. The total duration of the study is 78 weeks (including screening). Patients will be monitored for safety throughout the study. Study assessments at each study visit may include but are not limited to: blood and urine collection for testing, electrocardiogram (ECG) assessments (a measurement of the electrical activity of your heart), patient questionnaires, and physical examinations. TMC435 will be taken as an oral capsule of 150 mg once per day. Peginterferon (Pegasys ®) will be given as an injection of 180 µg once each week. Peginterferon (PegIntron®) will be given as an injection once each week and the dose will depend on your body weight. Ribavirin will be taken as a tablet (Copegus ®) or a capsule (Rebetol ®) twice each day and the dose will depend on your body weight.
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|Study Director:||Janssen R&D Ireland Clinical Trial||Janssen R&D Ireland|