A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.
Overview
- Phase
- Phase 2
- Intervention
- Alisporivir
- Conditions
- Hepatitis C
- Sponsor
- Debiopharm International SA
- Enrollment
- 52
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
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.
Exclusion Criteria
- Not provided
Arms & Interventions
Alisporivir 300 mg BID
Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Intervention: Alisporivir
Alisporivir 300 mg BID
Alisporivir (ALV) 300 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Intervention: Ribavirin
Alisporivir 400 mg BID
ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Intervention: Alisporivir
Alisporivir 400 mg BID
ALV 400 mg twice daily (BID) with ribavirin for 12 or 24 weeks based on Week 2 response, with a safety follow-up of at least 4 weeks, during which patients did not receive any study medication
Intervention: Ribavirin
Outcomes
Primary Outcomes
Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12
Time Frame: Baseline, Week 12
The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.
Change From Baseline in Alanine Aminotransferase (ALT) at Week 12
Time Frame: Baseline, Week 12
ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.
Secondary Outcomes
- Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment(Up to 24 weeks posttreatment)
- Percentage of Participants With Extended Rapid Virologic Response(2 weeks)
- Percentage of Participants With Rapid Virologic Response (RVR)(4 weeks)
- Percentage of Participants With End of Treatment Response (ETR)(Up to 24 weeks)
- Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End(Up to 24 weeks)