A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 Hepatitis C Virus (HCV)

Vertex Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00627926

VX07-950-108

Details and patient eligibility

About

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV).

Enrollment: 1,095 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,095 participants in 3 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 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.

Treatment:

Drug: Ribavirin

Biological: Pegylated Interferon Alfa 2a

Other: Placebo

Telaprevir 8 Week, PBO 4 Week+Peg-IFN-alfa-2a, RBV 24/48 Week

Experimental group

Description:

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.

Treatment:

Drug: Ribavirin

Biological: Pegylated Interferon Alfa 2a

Drug: Telaprevir

Other: Placebo

Telaprevir 12 Week+Peg-IFN-alfa-2a, RBV 24/48 Week

Experimental group

Description:

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.

Treatment:

Drug: Ribavirin

Biological: Pegylated Interferon Alfa 2a

Drug: Telaprevir