Phase 3
Completed N=540
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
Source: ClinicalTrials.gov NCT00758043 ↗Enrolled (actual)
540
Serious AEs
9.1%
Results posted
Jul 2011
Primary outcomePrimary: Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) — 149; 140; 76; 23 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Randomized Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Dose of Study Treatment (SVR24) |
149; 140; 76; 23; 149; 144 | — |
| SECONDARY Proportion of Subjects Who Have Undetectable HCV RNA at Week 72 |
141; 140; 76; 20 | — |
| SECONDARY Proportion of Subjects Achieving eRVR (Extended RVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12 |
162; 159; 0; 31 | — |
| SECONDARY Proportion of Randomized Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Dose of Study Treatment |
151; 144; 79; 28 | — |
| SECONDARY Proportion of Subjects Who Have Undetectable HCV RNA at the EOT (Week 24 or Week 48 Respectively) |
159; 154; 97; 59 | — |
| SECONDARY Proportion of Randomized Subjects Who Relapse |
9; 1; 5; 0 | — |
| SECONDARY Proportion of Enrolled Subjects Who Relapse |
9; 4; 11; 13 | — |
| SECONDARY Safety and Tolerability as Assessed by Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
161; 160; 117; 99; 4; 16 | — |
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT00758043). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.