A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)
Hepatitis C
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Genotype 1
Eligibility Criteria
Inclusion Criteria
- Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
- Male and female subjects, 18 to 70 years of age, inclusive
- Genotype 1, chronic hepatitis C with detectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
- Screening laboratory values, tests, and physical exam within acceptable ranges
- Able and willing to follow contraception requirements
- Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions
Exclusion Criteria
- Subject has any contraindications to Pegasys® or Copegus® therapy
- Evidence of hepatic decompensation in cirrhotic subjects
- History of organ transplant
- History of, or any current medical condition which could impact the safety of the subject in participation in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Experimental
Experimental
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week
Placebo (PBO) matched to telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
Telaprevir 750 mg tablet thrice daily for 8 weeks, then PBO matched to Telaprevir 750 mg tablet thrice daily for 4 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.
Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 to 48 weeks depending on individual response to telaprevir treatment.