Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
Hepatitis C, Chronic Pain
About this trial
This is an interventional treatment trial for Hepatitis C focused on measuring Chronic hepatitis C genotype 2, Chronic hepatitis C genotype 3, Cyclophilin inhibitor
Eligibility Criteria
Inclusion criteria:
- 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
Exclusion criteria:
- 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
Sites / Locations
- Scripps Clinic
- Sharp Rees-Stealy Medical Group, Inc.
- Research and Education Inc.
- Island View Gastroenterology Associates
- Hawai Medical Center East LLC
- Cotton O'Neil Clinical Research
- The Office of Dr. Claudia Martorell
- Saint Louis University
- Dartmouth-Hitchcock Medical Center
- Weill Cornell Medical Center
- Mount Sinai Medical Center
- Columbia University Medical Center
- The North Texas Research Institute
- Liver Associates of Texas
- Liver Specialist of Texas
- Alamo Medical Research
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Center
- Novartis Investigative Site
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- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Inestigative Site
- Novartis Investigative Site
- Novartis Inestigative Center
- Novartis Investigative Site
- Novartis Korea Ltd.
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Fundacion de Investigacion de Diego
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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- Novartis Investigative Site
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- Novartis Investigative Site
- Novartis Investigative Site
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- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Active Comparator
ALV 1000 mg
ALV 600 mg+RBV
ALV 800 mg+RBV
ALV 600 mg+PEG
PEG+RBV
Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with ribavirin (RBV) during Weeks 2 to 24.
Alisporivir (ALV) 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
Alisporivir (ALV) 600 mg BID with Peginterferon alfa-2a (PEG) for 1 week, followed by ALV 600 mg QD with PEG once weekly during Weeks 2 to 24.
Peginterferon alfa-2a (PEG) and RBV during Weeks 1 to 24.