A Study of Telaprevir (VX-950), Pegasys and Copegus in Hepatitis C (PROVE3)

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Telaprevir; Drug: Matching Placebo; Drug: Ribavirin; Drug: Pegylated Interferon Alfa 2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00420784

VX06-950-106

Details and patient eligibility

About

The PROVE3 trial is a partially double blinded, randomized, Phase 2 research study of an investigational drug, Telaprevir (VX-950) or Placebo, with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a, Pegasys®), and Ribavirin (RBV, Copegus®) in people with genotype 1 hepatitis C who have not achieved a Sustained Viral Response (SVR) with a previous treatment of interferon therapy.

Enrollment: 465 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females between 18 and 70 years old
• Detectable plasma hepatitis C virus (HCV) ribonucleic acid (RNA) greater than or equal to (>=) 10,000 international units per milliliter (IU/mL)
• Must have chronic hepatitis C (genotype 1) and have already received at least one prior course of pegylated interferon alfa 2a with ribavirin
• Cannot also be infected with Human Immunodeficiency Virus or hepatitis B
• Must be judged to be in general good health and able to receive Pegasys® and Copegus®
• No drug or alcohol abuse in the last year
• Must agree to use two effective methods of birth control during the study and for 6 months after you stop taking study medication. One of the methods needs to be a 'barrier' method (condom or diaphragm)
• If you are a woman, you cannot be in this study if you are pregnant or nursing

Exclusion criteria

• Participation in any clinical trial of a HCV protease inhibitor of any duration
• Prior response to therapy and failure to achieve SVR which was due to treatment non-compliance
• Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
• Diagnosed or suspected hepatocellular carcinoma
• History of or current evidence of decompensated liver disease
• Participation in any clinical trial of an investigational drug within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

465 participants in 4 patient groups, including a placebo group

Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week

Experimental group

Description:

Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir 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 24 weeks.

Treatment:

Drug: Pegylated Interferon Alfa 2a

Drug: Ribavirin

Drug: Telaprevir

Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week

Experimental group

Description:

Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 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 48 weeks.

Treatment:

Drug: Pegylated Interferon Alfa 2a

Drug: Ribavirin

Drug: Telaprevir

Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week

Experimental group

Description:

Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.

Treatment:

Drug: Pegylated Interferon Alfa 2a

Drug: Telaprevir

PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week

Placebo Comparator group

Description:

Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 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 48 weeks.

Treatment:

Drug: Pegylated Interferon Alfa 2a

Drug: Ribavirin

Drug: Matching Placebo