A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: Pegylated interferon alfa 2a; Drug: Telaprevir; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00535847

VX06-950-107

Details and patient eligibility

About

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

Enrollment: 117 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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117 participants in 3 patient groups

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

Experimental group

Description:

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 24 weeks.

Treatment:

Drug: Telaprevir

Drug: Pegylated interferon alfa 2a

Drug: Ribavirin

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

Treatment:

Drug: Telaprevir

Drug: Pegylated interferon alfa 2a

Drug: Ribavirin

Other

Experimental group

Description:

Subjects received telaprevir 750 mg 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 \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 \[NCT00535847\]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 \[NCT00336479\], VX05-950-104EU \[NCT00372385\] or VX06-950-106 \[NCT00420784\]) were included in "Other" reporting group.

Treatment:

Drug: Telaprevir

Drug: Pegylated interferon alfa 2a

Drug: Ribavirin