Phase 2
Completed N=52
Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option
Source: ClinicalTrials.gov NCT02094443 ↗Enrolled (actual)
52
Serious AEs
11.5%
Results posted
Oct 2016
Primary outcomePrimary: Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12 — 6.323; 6.343; -3.935; -3.855 log10 IU/mL
Summary
The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12 |
6.323; 6.343; -3.935; -3.855 | — |
| PRIMARY Change From Baseline in Alanine Aminotransferase (ALT) at Week 12 |
77.3; 67.9; -67.4; -58.2 | — |
| SECONDARY Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment |
30.8; 38.5; 19.2; 26.9; 19.2; 26.9 | — |
| SECONDARY Percentage of Participants With Extended Rapid Virologic Response |
0.0; 3.8 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) |
3.8; 15.4 | — |
| SECONDARY Percentage of Participants With End of Treatment Response (ETR) |
46.2; 50.0 | — |
| SECONDARY Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End |
73.1; 61.5; 38.5; 42.3 | — |
Eligibility Criteria
Inclusion Criteria
- Written informed consent must be obtained before any assessment is performed
- Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon
- Males or females aged ≥18 years
- Diagnosed Chronic hepatitis C virus infection
Exclusion criteria
- Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
- Hepatitis B surface antigen (HBsAg) positive
- Human immunodeficiency virus (HIV) positive
Other protocol-defined inclusion/exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT02094443). 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.