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 Incorporated540 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

540

Conditions

Hepatitis C

Interventions

telaprevirDRUG

750 mg every 8 hours (q8h) for 12 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (82)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Fresno, California, United States

Unnamed facility

La Jolla, California, United States

Unnamed facility

Outcomes

Primary Outcomes

Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24)

SVR24planned was used to measure the primary outcome. SVR24 planned is defined as undetectable HCV RNA levels at the end of treatment (EOT) visit and at 24 weeks after the last planned dose of study treatment without any confirmed detectable HCV RNA levels in between those visits. All plasma HCV RNA levels were assessed using the Roche TaqMan HCV RNA assay (Version 2.0, lower limit of quantification \[LLOQ\] of 25 IU/mL).

Time frame: 24 weeks after the last planned dose of study treatment

Secondary Outcomes

Proportion of Subjects Who Have Undetectable HCV RNA at Week 72

SVR at Week 72 is defined as achieved SVR24planned and undetectable HCV RNA at Week 72 without any confirmed detectable HCV RNA levels in between those visits.

Time frame: 72 weeks after the last planned dose of study treatment

Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12

Extended rapid viral response is defined undetectable HCV RNA levels at Week 4 and Week 12 (on treatment).

Time frame: Week 4 and Week 12

Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment

SVR12 is defined as undetectable HCV RNA levels 12 weeks after the last planned dose of study treatment.

Time frame: 12 weeks after last dose of study treatment

Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively)

Time frame: Week 24 or Week 48

Proportion of Randomized Subjects Who Relapse

Proportion of randomized subjects who relapsed was defined as the number of subjects who completed treatment, had undetectable HCV RNA at end of treatment (EOT; Week 24 or Week 48 respectively), and became HCV RNA detectable during antiviral follow-up (24 weeks after EOT).

Time frame: From EOT to Week 48 or Week 72

Proportion of Enrolled Subjects Who Relapse

Proportion of enrolled subjects who relapsed was defined as the number of subjects who had undetectable HCV RNA at the EOT, and became HCV RNA detectable during antiviral follow-up.

Time frame: From EOT to Week 48 or Week 72

Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Day 1 up to Week 72