Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1
NCT ID: NCT01446250
Last Updated: 2017-01-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
8 participants
INTERVENTIONAL
2011-12-31
2013-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alisporivir
At the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy.
Alisporivir
ALV 200 mg soft gel capsules administered orally
Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Ribavirin
RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Boceprevir
Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C).
Boceprevir
BOC 800 mg (4 x 200 mg soft gel capsules) administered orally
Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Ribavirin
RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Interventions
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Alisporivir
ALV 200 mg soft gel capsules administered orally
Boceprevir
BOC 800 mg (4 x 200 mg soft gel capsules) administered orally
Peginterferon alfa-2a
PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
Ribavirin
RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Debiopharm International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigational Site
Beverly Hills, California, United States
Novartis Investigational Site
Baltimore, Maryland, United States
Countries
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Other Identifiers
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CDEB025A2307
Identifier Type: -
Identifier Source: org_study_id
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