Phase 3
Completed N=662
A Safety and Effectiveness Study of Telaprevir in Chronic, Genotype 1, Hepatitis C Patients That Failed Previous Standard Treatment
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00703118 ↗
Enrolled (actual)
662
Serious AEs
8.4%
Results posted
Aug 2011
Primary outcomePrimary: Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned — 171; 175; 22 Participants — p=<0.001
Summary
The purpose of this study is to determine the safety, efficacy and tolerability of using two regimens of telaprevir (with and without delayed start) with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Sustained Virologic Response (SVR) 24 Weeks After the Last Planned Dose of Study Medication - SVR24 Planned |
171; 175; 22 | <0.001 sig |
| SECONDARY Number of Participants Acheiving Rapid Virologic Response (RVR) at Week 4 |
152; 188; 3 | — |
| SECONDARY Number of Participants Acheiving Undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 48 (End of Treatment) |
184; 191; 49 | — |
| SECONDARY Number of Participants With Sustained Virologic Response (SVR) 12 Weeks After the Last Planned Dose of Study Medication - SVR12 Planned |
175; 178; 22 | — |
| SECONDARY Number of Participants Who Meet the Telaprevir Stopping Rule at Week 4, Week 6, or Week 8 |
16; 14; 5; 2; 2; 0 | — |
| SECONDARY Number of Participants Who Have Viral Relapse During Entire Follow-up Period (up to Week 72) |
26; 27; 33 | — |
| SECONDARY Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 4 |
-5.5; -2.0; -1.9 | — |
| SECONDARY Number of Participants Acheiving Extended Rapid Virologic Response at Week 4 and Week 12 |
141; 180; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Patient must have chronic hepatitis C infection (genotype 1) with HCV RNA level >= 1000 IU/mL
- Patient must have failed at least 1 prior course of Peg-IFN/RBV therapy (standard treatment)
- Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria
- Patient is a previous non-responder that is classified as a viral breakthrough case
- Patient is infected with Hepatitis C virus, genotype 1, exhibiting more than one subtype
- Patient has Hepatitis C virus, genotype 1, and exhibits co-infection with any other genotype
- Evidence of decompensated liver disease
- Patient has condition that requires use of systemic corticosteroids
Data sourced from ClinicalTrials.gov (NCT00703118). 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.