Status:
COMPLETED
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)
Lead Sponsor:
AbbVie
Conditions:
Hepatitis C Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 virolog...
Detailed Description
This is a Phase 3, randomized, open-label, multicenter study evaluating the safety and efficacy of ombitasvir/paritaprevir/ritonavir coadministered with RBV for 12, 16, or 24 weeks in HCV genotype 4 (...
Eligibility Criteria
Inclusion
- For Arms A, B and C:
- \- Participants must meet one of the following:
- Treatment-naive: Participant has never received antiviral treatment for hepatitis C infection OR
- Treatment Experienced (Prior null responders, Partial responders or Relapsers to IFN/RBV);
- For Arm D:
- \- Participant must have prior treatment experience with SOF/pegIFN/RBV or SOF/RBV and meet one of the following categories:
- Prior SOF breakthrough/non-responder: HCV RNA detectable at the end of treatment with SOF/pegIFN/RBV or SOF/RBV;
- Prior SOF relapser: achieved HCV RNA undetectable at end of a prior treatment course SOF/pegIFN/RBV or SOF/RBV, but HCV RNA was detectable within 52 weeks following completion of therapy.
- For Arms A, B, C and D:
- Chronic HCV genotype 4 infection with cirrhosis.
- Participant has plasma HCV RNA level \> 1,000 IU/mL at Screening
Exclusion
- 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 paritaprevir 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.
Key Trial Info
Start Date :
October 28 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2017
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT02265237
Start Date
October 28 2014
End Date
April 7 2017
Last Update
August 31 2017
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.