Hepatitis C Virus Clinical Trial
Official title:
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)
The purpose of this study in HCV genotype 4-infected subjects with compensated cirrhosis is
to assess the safety and to compare the percentage of subjects 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 subjects treated with pegylated interferon (pegIFN)/RBV].
The 12 and 16-week arms have been fully enrolled. As of 19 May 2015, they were closed and
the two 24-week arms were opened for enrollment.
n/a
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