Status:
TERMINATED
Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
Lead Sponsor:
Debiopharm International SA
Conditions:
Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Chronic HCV genotype 1 infection
- No previous treatment for HCV infection
- African American ethnicity
- Serum HCV RNA ≥ 1000 IU/ml, assessed by quantitative polymerase chain reaction or equivalent at screening visit, no upper limit
- A liver biopsy within 3 years prior to baseline
- Exclusion criteria:
- HCV genotype different from genotype 1 or co-infection with other HCV genotype
- Co-infection with Hepatitis B or HIV
- Any other cause of relevant liver disease other than HCV
- Presence or history of hepatic decompensation
- Alanine aminotransferase (ALT) ≥ 10 times ULN, more than 1 episode of elevated bilirubin (\> ULN) in past 6 months
- Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01446250
Start Date
December 1 2011
End Date
May 1 2013
Last Update
January 16 2017
Active Locations (2)
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1
Novartis Investigational Site
Beverly Hills, California, United States, 90211
2
Novartis Investigational Site
Baltimore, Maryland, United States, 21229