Phase 3
Completed N=51
Study of Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Relapsed After Treatment (MK-7009-044)
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01405937 ↗
Enrolled (actual)
51
Serious AEs
9.8%
Results posted
Oct 2014
Primary outcomePrimary: Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24) — 92.0; 96.2 percentage of participants — p=<0.001
Summary
The purpose of this study is to evaluate the safety, tolerability, and efficacy of vaniprevir given in combination with pegylated interferon alfa-2b (PegIntron®/peg-IFN) and ribavirin (RBV) in chronic hepatitis C (CHC) Genotype I (GT 1) participants who relapsed after previous therapy with interferon-based therapy. The primary efficacy hypothesis is that the percentage of participants achieving sustained virologic response 24 weeks after completion of all study therapy (SVR24) in at least one of the vaniprevir 300 mg twice daily treatment regimens is greater than 20% (historical data of standard of care treatment).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Sustained Virologic Response 24 Weeks After Completion of All Study Therapy (SVR24) |
92.0; 96.2 | <0.001 sig |
| PRIMARY Percentage of Participants With One or More Specific Adverse Events (AEs) of Special Interest During the Study |
88.0; 84.6; 56.0; 61.5; 8.0; 3.8 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an AE |
4.0; 0.0 | — |
| SECONDARY Percentage of Participants Achieving SVR12 |
88.0; 92.3 | — |
| SECONDARY Percentage of Participants Achieving Rapid Virologic Response (RVR) |
88.0; 88.5 | — |
| SECONDARY Percentage of Participants Achieving Complete Early Virologic Response (cEVR) |
100.0; 100.0 | — |
| SECONDARY Percentage of Participants Achieving Undetectable HCV RNA at the End of Treatment (EOT) |
100.0; 100.0 | — |
| SECONDARY Mean Change From Baseline in HCV RNA (Log 10) |
-5.7; -5.7; -6.5; -6.3; -6.6; -6.5 | — |
Eligibility Criteria
Inclusion Criteria
- Japanese participant diagnosed with compensated CHC GT 1
- Absence of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of advanced liver disease
- Has received and tolerated treatment with IFN-based therapy (IFN α, IFN β, or peg-IFN) with or without use of ribavirin, but failed to respond to the prior treatment (relapse or breakthrough)
- No evidence of cirrhosis
Exclusion Criteria
- Co-infection with human immunodeficiency virus (HIV)
- Positive hepatitis B surface antigen or other evidence of active hepatitis B infection
- Any other condition that is contraindicated or for which caution is required for treatment with peg-IFN or RBV
- Any condition or pre-study laboratory abnormality, or history of any illness, that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering the study drugs, peg-IFN and RBV, to the participant
Data sourced from ClinicalTrials.gov (NCT01405937). 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.