Status:
COMPLETED
Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
Lead Sponsor:
Debiopharm International SA
Conditions:
Hepatitis C
Chronic Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT01215643
Start Date
October 1 2010
End Date
May 1 2012
Last Update
August 30 2016
Active Locations (73)
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1
Scripps Clinic
La Jolla, California, United States, 92037
2
Sharp Rees-Stealy Medical Group, Inc.
San Diego, California, United States, 92101
3
Research and Education Inc.
San Diego, California, United States, 92105
4
Island View Gastroenterology Associates
Ventura, California, United States, 93003