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

Debiopharm

Status: Completed

Conditions: Hepatitis C; Liver Disease

Treatments: Drug: Peg-IFNα2a; Drug: Alisporivir; Drug: Ribavirin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01970904

2012-004185-17 (EudraCT Number)

CDEB025A2222

Details and patient eligibility

About

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.

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment.

2. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes

3. Hepatitis B Surface Antigen (HBsAg) positive

4. Human immunodeficiency virus (HIV) positive.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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147 participants in 3 patient groups

200 mg BID

Experimental group

Description:

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).

Treatment:

Drug: Ribavirin

Drug: Alisporivir

Drug: Peg-IFNα2a

300 mg BID

Experimental group

Description:

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).

Treatment:

Drug: Ribavirin

Drug: Alisporivir

Drug: Peg-IFNα2a

400 mg BID

Experimental group

Description:

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).

Treatment:

Drug: Ribavirin

Drug: Alisporivir

Drug: Peg-IFNα2a