Status:
TERMINATED
Alisporivir With PEG and RBV in Protease Inhibitor (PI) Treatment Failure Patients With Chronic Hepatitis C
Lead Sponsor:
Debiopharm International SA
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study is to evaluate the overall efficacy, and safety profile of the triple combination therapy of alisporivir (ALV; DEB025) plus peginterferon alfa-2a (PEG) and ribavirin (RBV) patients with chr...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients with chronic HCV genotype 1 infection with previous PI treatment failure
- Three months minimum time from the last dose of previous PI treatment to the first dose of study medication
- Exclusion criteria:
- Use of other investigational drugs at the time of enrollment
- History of hypersensitivity to PEG or RBV
- Any null non-responders to prior PEG/RBV treatment
- Other protocol-defined inclusion/exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01500772
Start Date
March 1 2012
End Date
May 1 2012
Last Update
August 1 2016
Active Locations (60)
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1
Novartis Investigative Site
Phoenix, Arizona, United States, 85054
2
Novartis Investigative Site
Bakersfield, California, United States, 93301
3
Novartis Investigative Site
Los Angeles, California, United States, 90033
4
Novartis Investigative Site
Palo Alto, California, United States, 95128