Alisporivir (Deb025) and Boceprevir Triple Therapies in African American Participants Not Previously Treated for Chronic Hepatitis C Genotype 1

Stopped early · Phase 3

Conditions studied: Hepatitis C

In brief

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 have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.

Key facts

Study ID

NCT01446250

Run by

Debiopharm International SA

People needed

8

Starts

2011-12-01

Expected to finish

2013-05-01

Last updated by the study team

2017-01-16

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Novartis Investigational Site — Beverly Hills, California, United States
• Novartis Investigational Site — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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