Phase 2
Completed N=340
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
Source: ClinicalTrials.gov NCT01215643 ↗Enrolled (actual)
340
Serious AEs
4.0%
Results posted
Aug 2016
Primary outcomePrimary: Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ) — 28.4; 36.9; 41.9; 84.6 percentage of participants
Summary
The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ) |
28.4; 36.9; 41.9; 84.6; 72.5 | — |
| SECONDARY Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD) |
18.5; 14.3; 23.7; 69.2; 60.0 | — |
| SECONDARY Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2) |
21.7; 23.3; 46.2; 81.8; 76.9; 13.0 | — |
| SECONDARY Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3) |
31.0; 44.4; 40.3; 85.7; 70.4; 20.7 | — |
| SECONDARY Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD) |
93.8; 95.2; 90.3; 94.9; 85.0; 91.4 | — |
| SECONDARY Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2) |
100.0; 96.7; 80.8; 100.0; 84.6; 100.0 | — |
| SECONDARY Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3) |
91.4; 94.4; 94.0; 92.9; 85.2; 87.9 | — |
| SECONDARY Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD) |
95.1; 96.4; 95.7; 94.9; 87.5; 92.6 | — |
| SECONDARY Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2) |
100.0; 96.7; 84.6; 100.0; 92.3; 100.0 | — |
| SECONDARY Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3) |
93.1; 96.3; 100.0; 92.9; 85.2; 89.7 | — |
| SECONDARY Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD) |
81.5; 84.5; 80.6; 76.9; 62.5; 80.2 | — |
| SECONDARY Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2) |
78.3; 76.7; 76.9; 72.7; 61.5; 78.3 | — |
| SECONDARY Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3) |
82.8; 88.9; 82.1; 78.6; 63.0; 81.0 | — |
| SECONDARY Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD) |
80.2; 84.5; 80.6; 79.5; 57.5; 80.2 | — |
| SECONDARY Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2) |
78.3; 76.7; 76.9; 72.7; 53.8; 78.3 | — |
| SECONDARY Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3) |
81.0; 88.9; 82.1; 82.1; 59.3; 81.0 | — |
| SECONDARY Percentage of Participants With On-treatment Viral Breakthrough |
2.5; 3.6; 2.2; 5.1; 0.0 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
9.9; 8.3; 6.5; 10.3; 20.0; 1.2 | — |
Eligibility Criteria
Inclusion criteria
- Chronic hepatitis C viral infection
- Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
- HCV genotype 2 or 3
- No previous treatment for hepatitis C infection
Exclusion criteria
- Evidence of cirrhosis at the time of screening
- Evidence of hepatocellular carcinoma at the time of screening
- Any other cause of relevant liver disease other than HCV
- Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
- Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01215643). 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.