Phase 3
Completed N=644
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
Source: ClinicalTrials.gov NCT01598090 ↗Enrolled (actual)
644
Serious AEs
10.7%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A — 51.9 Percentage of participants
◆ Published Evidence
Highly cited
151citations · ~12 / year
25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end.
Summary
The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.
Linked Publications
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25 years of interferon-based treatment of chronic hepatitis C: an epoch coming to an end.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A |
51.9 | — |
| PRIMARY Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B |
76.2; 82 | 0.0855 |
| PRIMARY Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A |
26; 6; 12; 2; 0; 3 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A |
48.1 | — |
| SECONDARY Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A |
40.7 | — |
| SECONDARY Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B |
73.6; 81.9 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B |
11.7; 55.8 | — |
| SECONDARY Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B |
64; 70.9 | — |
| SECONDARY Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B |
14.4; 36.4; 21.4; 30.6 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B |
83; 87 | — |
| SECONDARY Percentage of Participants With Rash |
63; 36.3; 38.3 | — |
Eligibility Criteria
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria
- Chronic hepatitis C genotype 1. GT-1b Capped at 50 % of naïve subjects
- Naives to prior anti-HCV therapy [Interferon (IFN) and direct antiviral agent (DAA) based]
- Relapsers (defined as subjects who had undetectable HCV ribonucleic acid (RNA) on prior treatment regimen of alfa-2a/RBV and Hepatitis C Virus (HCV) RNA > 25IU/mL after discontinuation of treatment). Capped at 20%
- HCV RNA ≥ 100,000 IU/mL
- Subjects with compensated cirrhosis can be enrolled and will be capped at approximately 10%
- Seronegative for human immunodeficiency virus (HIV) and hepatitis B surface antigen (HBsAg)
- Men or women, 18-70 years of age
Exclusion Criteria
- Chronic liver disease due to causes other than chronic HCV
- Current or past evidence of decompensation
- Conditions that preclude the use of Alfa/RBV/TVR per respective labels
- Diagnosed or suspected hepatocellular carcinoma
Data sourced from ClinicalTrials.gov (NCT01598090) and the linked publication. 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.