Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

Completed · Phase 3 · Has a placebo group

Conditions studied: Hepatitis C

In brief

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

Key facts

Study ID

NCT01318694

Run by

Debiopharm International SA

People needed

1081

Starts

2011-03-01

Expected to finish

2013-08-01

Last updated by the study team

2016-09-30

Who can join

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

You may qualify if…

• Chronic HCV infection
• HCV genotype 1
• No previous treatment for hepatitis C infection
• Serum HCV RNA level ≥ 1000 IU/ml assessed by quantitative polymerase chain reaction or equivalent at screening, no upper limit
• Liver evaluation prior to baseline: liver biopsy within 3 years or Fibroscan within 6 months

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 upper limit of normal (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 Investigative Site — Oakland, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — San Diego, California, United States
• Novartis Investigative Site — Ventura, California, United States
• Novartis Investigative Site — Bradenton, Florida, United States
• Novartis Investigative Site — Maitland, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Indianapolis, Indiana, United States
• Novartis Investigative Site — Shreveport, Louisiana, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Baltimore, Maryland, United States
• Novartis Investigative Site — Minneapolis, Minnesota, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — St Louis, Missouri, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Newark, New Jersey, United States
• Novartis Investigative Site — Brooklyn, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Charlotte, North Carolina, United States
• Novartis Investigative Site — Fayetteville, North Carolina, United States
• Novartis Investigative Site — Arlington, Texas, United States
• Novartis Investigative Site — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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