Phase 3
Completed N=1,081
Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants
Source: ClinicalTrials.gov NCT01318694 ↗Enrolled (actual)
1,081
Serious AEs
9.4%
Results posted
Sep 2016
Primary outcomePrimary: Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12) — 68.6; 68.9; 69.4; 52.5 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy [i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Achieved Sustained Virologic Response (SVR) 12 Weeks After the End of Treatment (SVR12) |
68.6; 68.9; 69.4; 52.5 | — |
| SECONDARY Percentage of Participants Who Achieved SVR 24 Weeks After the End of Treatment (SVR24) |
68.5; 69.0; 68.3; 51.7 | — |
| SECONDARY Percentage of Participants With Rapid Virologic Response (RVR) After 4 Weeks of Treatment (RVR4) |
60.1; 72.5; 56.6; 28.4 | — |
| SECONDARY Percentage of Participants With Early Virologic Response (EVR) After 12 Weeks of Treatment |
97.7; 98.3; 99.6; 89.8 | — |
| SECONDARY Percentage of Participants With Partial Early Virologic Response (pEVR) After 12 Weeks of Treatment |
8.1; 2.1; 10.5; 19.5 | — |
| SECONDARY Percentage of Participants With Complete Early Virologic Response (cEVR) After 12 Weeks of Treatment |
89.6; 96.3; 89.1; 70.3 | — |
| SECONDARY Percentage of Participants With Extended Rapid Virologic Response (eRVR) From 4 to 12 Weeks of Treatment |
60.2; 71.1; 56.7; 28.1 | — |
| SECONDARY Percentage of Participants With End of Treatment Response (ETR) at Treatment End Within 48 Weeks |
88.2; 87.7; 87.5; 80.0 | — |
| SECONDARY Percentage of Participants With Alanine Aminotransferase (ALT) Abnormalities Within 48 Weeks |
1.5; 0.4; 1.9; 1.5; 0.7; 0.0 | — |
| SECONDARY Percentage of Participants With Grade 3 or 4 Anemia During Treatment Within 48 Weeks |
1.8; 3.4; 0.8; 1.9; 0.0; 0.4 | — |
| SECONDARY Percentage of Participants With Grade 3 or 4 Neutropenia During Treatment Within 48 Weeks |
24.4; 24.7; 23.1; 12.9; 4.4; 8.0 | — |
| SECONDARY Percentage of Participants With Grade 3 or 4 Thrombocytopenia During Treatment Within 48 Weeks |
6.7; 21.9; 12.5; 1.9; 0.0; 1.1 | — |
Eligibility Criteria
Inclusion criteria
- Chronic HCV infection
- HCV genotype 1
- No previous treatment for hepatitis C infection
- Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
- Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months
Exclusion criteria
- HCV genotype different from genotype 1 or co-infection with other HCV genotype
- Co-infection with Hepatitis B or HIV
- Any other cause of relevant liver disease other than HCV
- Presence or history of hepatic decompensation
- Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN), more than 1 episode of elevated bilirubin (> ULN) in past 6 months
Other protocol-defined inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01318694). 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.