Pharmacokinetics, Pharmacodynamics and Safety of DEB025 Plus Ribavirin in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients

Study Overview
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Brief Summary
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This study will explore the relationship of different DEB025 doses in combination with RBV to pharmacokinetic, pharmacodynamic (i.e. viral load reduction) and safety profiles in chronic hepatitis C GT 2 and 3 treatment naïve patients.

Official Title
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A Multicenter, Open-label, Randomized, 3-arm, Phase II Profiling Trial of Pharmacokinetics, Pharmacodynamics and Safety of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Treatment naïve Patients

Conditions
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Hepatitis C, Liver Disease

Intervention / Treatment
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* Drug: Alisporivir
* Drug: Ribavirin
* Drug: Peg-IFNα2a


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. No previous treatment for Hepatitis C (HCV) infection (i.e. HCV treatment-naïve) Chronic hepatitis C (G2 or G3) virus infection diagnosed 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. -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 200 mg BID<br>Dual-therapy with a response-guided treatment duration with Alisporivir 200 mg twice daily (BID) and Ribavirin (RBV) for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm). | Drug: Alisporivir<br>* Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration<br>* Other names: DEB025;Drug: Ribavirin<br>* Ribavirin tablets of various strengths for oral administration<br>* Other names: RBV;Drug: Peg-IFNα2a<br>* Peg-IFNα2a solution for subcutaneous injection<br>|
| Experimental: 300 mg BID<br>Dual-therapy with a response-guided treatment duration with Alisporivir 300mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm). | Drug: Alisporivir<br>* Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration<br>* Other names: DEB025;Drug: Ribavirin<br>* Ribavirin tablets of various strengths for oral administration<br>* Other names: RBV;Drug: Peg-IFNα2a<br>* Peg-IFNα2a solution for subcutaneous injection<br>|
| Experimental: 400 mg BID<br>Dual-therapy with a response-guided treatment duration with Alisporivir 400 mg BID and RBV for 12 or 24 weeks (Treatment period 1). Patients who were considered treatment failures were to be treated with peg-IFNα2a/RBV 800 mg daily for 24 weeks in Treatment period 2 (Roll-over treatment arm). | Drug: Alisporivir<br>* Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration<br>* Other names: DEB025;Drug: Ribavirin<br>* Ribavirin tablets of various strengths for oral administration<br>* Other names: RBV;Drug: Peg-IFNα2a<br>* Peg-IFNα2a solution for subcutaneous injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load drop from baseline through Week 12 |  | Baseline through Week 12 | 
| Percentage of participants who developed confirmed Stage II or greater hypertension (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg |  | within 12 weeks | 
| Change in platelet count from baseline through Week 12. |  | Baseline through Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Sustained Virologic Response at Week 12 follow-up (SVR12) |  | 12 weeks after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C, DEB025, Alisporivir, ribavirin therapy, genotype 2/3 treatment naive patients