Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic Pain

In brief

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

Key facts

Study ID

NCT01215643

Run by

Debiopharm International SA

People needed

340

Starts

2010-10-01

Expected to finish

2012-05-01

Last updated by the study team

2016-08-30

Who can join

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

You may qualify if…

• Chronic hepatitis C viral infection
• Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
• HCV genotype 2 or 3
• No previous treatment for hepatitis C infection

You may not qualify if…

• Evidence of cirrhosis at the time of screening
• Evidence of hepatocellular carcinoma at the time of screening
• Any other cause of relevant liver disease other than HCV
• Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Sharp Rees-Stealy Medical Group, Inc. — San Diego, California, United States
• Research and Education Inc. — San Diego, California, United States
• Island View Gastroenterology Associates — Ventura, California, United States
• Hawai Medical Center East LLC — Honolulu, Hawaii, United States
• Cotton O'Neil Clinical Research — Topeka, Kansas, United States
• The Office of Dr. Claudia Martorell — Springfield, Massachusetts, United States
• Saint Louis University — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Weill Cornell Medical Center — New York, New York, United States
• Mount Sinai Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• The North Texas Research Institute — Arlington, Texas, United States
• Liver Associates of Texas — Houston, Texas, United States
• Liver Specialist of Texas — Houston, Texas, United States
• Alamo Medical Research — 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 Center — Greenslopes, Queensland, Australia
• Novartis Investigative Site — Clayton, Victoria, Australia
• Novartis Investigative Site — Fitzroy, Victoria, Australia
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ghent, Belgium
• Novartis Investigative Site — Leuven, Belgium
• Scripps Clinic — La Jolla, California, United States

Full record on ClinicalTrials.gov

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