Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option

Completed · Phase 2

Conditions studied: Hepatitis C, Liver Disease

In brief

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.

Key facts

Study ID

NCT02094443

Run by

Debiopharm International SA

People needed

52

Starts

2014-03-01

Expected to finish

2015-04-01

Last updated by the study team

2016-10-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Bakersfield, California, United States
• Novartis Investigative Site — Lancaster, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Arlington, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Newport News, Virginia, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Seattle, Washington, United States
• Novartis Investigative Site — Clichy, France
• Novartis Investigative Site — Créteil, France
• Novartis Investigative Site — Lyon, France
• Novartis Investigative Site — Nice, France
• Novartis Investigative Site — Paris, France

Full record on ClinicalTrials.gov

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