Status:
COMPLETED
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
Lead Sponsor:
Debiopharm International SA
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
459 Patients enrolled
Trial Details
Trial ID
NCT01183169
Start Date
August 1 2010
End Date
May 1 2013
Last Update
August 25 2016
Active Locations (75)
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1
Novartis Investigative Site
San Diego, California, United States, 92101
2
Novartis Investigative Site
San Diego, California, United States, 92115
3
Novartis Investigative Site
Ventura, California, United States, 93003
4
Novartis Investigative Site
Bradenton, Florida, United States, 34209