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

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiopharm International SA
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

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.

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