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)
AGATE-1
2 other identifiers
interventional
184
0 countries
N/A
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 virologic response (SVR12), \[HCV ribonucleic acid (RNA) \< lower limit of quantification (LLOQ) 12 weeks following treatment\], to a clinically relevant threshold \[based on SVR rates for HCV genotype 4-infected participants treated with pegylated interferon (pegIFN)/RBV\].
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Oct 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2014
CompletedFirst Posted
Study publicly available on registry
October 15, 2014
CompletedStudy Start
First participant enrolled
October 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 7, 2017
CompletedResults Posted
Study results publicly available
August 31, 2017
CompletedAugust 31, 2017
August 1, 2017
1.8 years
October 10, 2014
April 26, 2017
August 1, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants in Arms A, B and C With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)
SVR12 was defined as plasma hepatitis C virus ribonucleic acid (HCV RNA) level less than the lower limit of quantification (\<LLOQ) 12 weeks after the last dose of study drug.
12 weeks after the last actual dose of study drug
Secondary Outcomes (4)
Percentage of Participants With SVR12 in Participants Receiving 12 Weeks (Arm A) of Treatment Compared to Participants Receiving 16 Weeks of Treatment (Arm B)
12 weeks after the last actual dose of study drug
Percentage of Participants With SVR12 in Participants Receiving 16 Weeks (Arm B) of Treatment Compared to Participants Receiving 24 Weeks of Treatment (Arm C)
12 weeks after the last actual dose of study drug
Percentage of Participants in Arms A, B and C With On-treatment Virologic Failure
Up to Treatment Week 24 (end of treatment) or premature discontinuation from treatment
Percentage of Participants in Arms A, B and C With Post-treatment Relapse
From the end of treatment through 12 weeks after the last dose of study drug
Study Arms (4)
Arm A
EXPERIMENTALOmbitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 12 weeks for genotype 4 treatment-naïve or treatment-experienced with IFN/RBV.
Arm B
EXPERIMENTALOmbitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 16 weeks for genotype 4 treatment-naive or treatment-experienced with IFN/RBV.
Arm C
EXPERIMENTALOmbitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV.
Arm D
EXPERIMENTALOmbitasvir/paritaprevir/ritonavir (25/150/100 mg) and Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment-experienced.
Interventions
tablets
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Related Publications (1)
Asselah T, Hezode C, Qaqish RB, ElKhashab M, Hassanein T, Papatheodoridis G, Feld JJ, Moreno C, Zeuzem S, Ferenci P, Yu Y, Redman R, Pilot-Matias T, Mobashery N. Ombitasvir, paritaprevir, and ritonavir plus ribavirin in adults with hepatitis C virus genotype 4 infection and cirrhosis (AGATE-I): a multicentre, phase 3, randomised open-label trial. Lancet Gastroenterol Hepatol. 2016 Sep;1(1):25-35. doi: 10.1016/S2468-1253(16)30001-2. Epub 2016 Jun 16.
PMID: 28404108DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Information
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 10, 2014
First Posted
October 15, 2014
Study Start
October 28, 2014
Primary Completion
July 28, 2016
Study Completion
April 7, 2017
Last Updated
August 31, 2017
Results First Posted
August 31, 2017
Record last verified: 2017-08