Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C

In brief

The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

Key facts

Study ID

NCT01183169

Run by

Debiopharm International SA

People needed

459

Starts

2010-08-01

Expected to finish

2013-05-01

Last updated by the study team

2016-08-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic HCV genotype 1 viral infection
• HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
• Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks

You may not qualify if…

• Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
• Women of child-bearing potential unless using highly effective
• Any other cause of relevant liver disease other than HCV
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Ventura, California, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Orlando, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Honolulu, Hawaii, United States
• Novartis Investigative Site — Honolulu, Hawaii, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Springfield, Massachusetts, United States
• Novartis Investigative Site — Egg Harbor Twp, New Jersey, United States
• Novartis Investigative Site — Brooklyn, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Arlington, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — San Antonio, Texas, United States
• Novartis Investigative Site — Kingswood, New South Wales, Australia
• Novartis Investigative Site — Kogarah, New South Wales, Australia
• Novartis Investigative Site — Westmead, New South Wales, Australia
• Novartis Investigative Site — Clayton, Victoria, Australia
• Novartis Investigative Site — Fitzroy, Victoria, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Novartis Investigative Site — San Diego, California, United States

Full record on ClinicalTrials.gov

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