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)
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Hepatitis, Hepatitis, Hepatitis |
Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 99 |
Updated: | 4/27/2017 |
Start Date: | October 28, 2014 |
End Date: | April 7, 2017 |
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.
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.
Inclusion Criteria:
- Subjects must meet one of the following:
Treatment-naive (Subject has never received antiviral treatment for hepatitis C infection)
OR For Arms A, B, and C:
- Treatment Experienced (Prior null responders, Partial responders or Relapsers to
IFN/RBV)
For Arm D:
- Treatment Experienced (Prior sofosbuvir (SOF) breakthrough/non-responder or Prior SOF
relapser to SOF/pegIFN/RBV or SOF/RBV)
- Subject has plasma HCV RNA > 1000 IU/mL at Screening
- Chronic HCV genotype 4 infection with cirrhosis
Exclusion Criteria:
- Positive test result at Screening for Hepatitis B surface antigen (HBsAg) or
anti-human immunodeficiency virus antibody (HIV Ab).
- Current enrollment in another interventional clinical study, previous enrollment in
this study, or previous use of any protease inhibitor, non-nucleoside polymerase
inhibitor, or Nonstructural viral protein (NS) 5A inhibitor, either investigational
or commercially available (including previous exposure to ABT-450 or ombitasvir), or
receipt of any investigational product within 6 weeks prior to study drug
administration. Prior use of any direct-acting antiviral will not be allowed, except
for Arm D where prior experience with the nucleoside polymerase inhibitor, sofosbuvir
with pegIFN/RBV or SOF with RBV is required.
- Any current or past clinical evidence of Child-Pugh B or C classification or clinical
history of liver decompensation including ascites, variceal bleeding, or hepatic
encephalopathy.
- Confirmed presence of hepatocellular carcinoma.
- Any cause of liver disease other than chronic HCV infection.
- Abnormal laboratory tests.
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