A Study Evaluating 24-Week and 48-Week Telaprevir-Based Regimen in Treatment Naïve Subjects With Genotype 1 Chronic Hepatitis C Who Achieve an Extended Rapid Viral Response

Vertex Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Hepatitis C

Treatments: Drug: ribavirin; Biological: peginterferon alfa-2a; Drug: telaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00758043

EudraCT 2008-003836-39

VX08-950-111

Details and patient eligibility

About

This study is being conducted to learn more about the safety and effect of telaprevir in combination with peginterferon alfa-2a (PEG-IFN) and ribavirin (RBV) in participants with hepatitis C who have never been treated for their hepatitis C virus (HCV). The study is designed to look at the relative benefits of 24 or 48 weeks of total treatment in people who respond quickly to a telaprevir-based treatment.

Enrollment: 540 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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 HCV 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: None (Open label)

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540 participants in 4 patient groups

T12PR24 (eRVR+)

Experimental group

Description:

Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 12 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group

Treatment:

Drug: telaprevir

Biological: peginterferon alfa-2a

Drug: ribavirin

T12PR48 (eRVR+)

Experimental group

Description:

Randomized Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects achieved an extended rapid viral response (eRVR+) and were randomized to this group

Treatment:

Drug: telaprevir

Biological: peginterferon alfa-2a

Drug: ribavirin

T12PR48 (eRVR-)

Experimental group

Description:

Assigned Group: Telaprevir + Peg-IFN-alfa-2a + RBV for 12 weeks, followed by Peg-IFN-alfa-2a + RBV for 36 weeks; subjects did not achieve an extended rapid viral response and were assigned to this group

Treatment:

Drug: telaprevir

Biological: peginterferon alfa-2a

Drug: ribavirin

Other

Experimental group

Description:

Other Group: Subjects who received at least 1 dose of study drug, but prematurely discontinued treatment before Week 20, were not randomized or assigned to a treatment regimen.

Treatment:

Drug: telaprevir

Biological: peginterferon alfa-2a

Drug: ribavirin