Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00336479

VX05-950-104

Details and patient eligibility

About

Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

Enrollment: 263 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
• Have been infected with hepatitis C virus for greater than (>) 6 months
• Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2
• Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
• Female subjects must have a negative pregnancy test at all visits before the first dose

Exclusion criteria

• Received any approved or investigational drug or drug regimen for the treatment of hepatitis C
• Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy
• 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
• Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start
• Alcohol abuse or excessive use in the last 12 months
• Participation in any investigational drug study 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

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263 participants in 4 patient groups, including a placebo group

PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week

Placebo Comparator group

Description:

Placebo (PBO) matched to telaprevir tablet orally 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.

Treatment:

Other: Placebo

Drug: Pegylated Interferon Alfa 2a

Drug: Ribavirin

Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week

Experimental group

Description:

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 48 weeks.

Treatment:

Drug: Pegylated Interferon Alfa 2a

Drug: Ribavirin

Drug: Telaprevir

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

Experimental group

Description:

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 weeks.

Treatment:

Drug: Pegylated Interferon Alfa 2a

Drug: Ribavirin

Drug: Telaprevir

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

Experimental group

Description:

Single loading dose of telaprevir 1250 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 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 12 weeks.

Treatment:

Drug: Pegylated Interferon Alfa 2a

Drug: Ribavirin

Drug: Telaprevir