Phase 2
Completed N=459
Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment
Source: ClinicalTrials.gov NCT01183169 ↗Enrolled (actual)
459
Serious AEs
5.3%
Results posted
Aug 2016
Primary outcomePrimary: Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ) — 48.2; 61.1; 35.5; 74.3 percentage of participants
Summary
The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ) |
48.2; 61.1; 35.5; 74.3; 45.5; 80.0 | — |
| SECONDARY Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD) |
39.1; 41.7; 20.9; 58.7; 39.4; 73.3 | — |
| SECONDARY Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD |
42.7; 51.9; 14.5; 65.1; 18.2; 53.3 | — |
| SECONDARY Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD |
41.8; 51.9; 14.5; 65.1; 18.2; 53.3 | — |
| SECONDARY Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD |
20.9; 25.0; 7.3; 41.3; 39.4; 56.7 | — |
| SECONDARY Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD |
38.2; 28.7; 31.8; 11.9; 3.0; 6.7 | — |
| SECONDARY Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD |
68.2; 74.1; 33.6; 82.6; 51.5; 73.3 | — |
| SECONDARY Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End |
77.4; 77.6; 59.0; 83.0; 35.7; 28.6 | — |
| SECONDARY Percentage of Participants With On-treatment Viral Breakthrough |
12.7; 9.3; 5.5; 2.8; 6.1; 10.0 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
19.1; 18.5; 17.3; 12.8; 30.3; 13.3 | — |
Eligibility Criteria
Inclusion criteria
- Chronic HCV genotype 1 viral infection
- HCV RNA ≥ 1, 000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
- Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks
Exclusion criteria
- Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
- Women of child-bearing potential unless using highly effective
- Any other cause of relevant liver disease other than HCV
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01183169). 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.