A Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Ombitasvir/ABT-450/Ritonavir Co-administered With Ribavirin (RBV) in Adults With Genotype 4 Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis (AGATE-1)

Study Identifier
M11-665
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Hepatitis
  • Study Drug
  • ombitasvir/paritaprevir/ritonavir
  • ribavirin
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    The purpose of this study in HCV genotype 4-infected participants with compensated cirrhosis is to assess the safety and to compare the percentage of participants achieving a 12-week sustained virologic response (SVR12), \[HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment\], to a clinically relevant threshold \[based on SVR rates for HCV genotype 4-infected participants treated with pegylated interferon (pegIFN)/RBV\].

    Study Locations

    No locations found.