Overview

This trial is active, not recruiting.

Condition hepatitis c virus
Treatments ombitasvir/abt-450/ritonavir, ribavirin
Phase phase 3
Sponsor AbbVie
Start date October 2014
End date May 2016
Trial size 190 participants
Trial identifier NCT02265237, 2014-001496-31, M11-665

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ombitasvir/ABT-450/ritonavir + Ribavirin dosed for 12 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV only
ombitasvir/abt-450/ritonavir
tablets
ribavirin
tablets
(Experimental)
Ombitasvir/ABT-450/ritonavir + Ribavirin dosed for 16 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV only
ombitasvir/abt-450/ritonavir
tablets
ribavirin
tablets
(Experimental)
Ombitasvir/ABT-450/ritonavir + Ribavirin dosed for 24 weeks for genotype 4 treatment-naive and treatment-experienced with IFN/RBV only
ombitasvir/abt-450/ritonavir
tablets
ribavirin
tablets
(Experimental)
Ombitasvir/ABT-450/ritonavir + Ribavirin dosed for 24 weeks for genotype 4 SOF/pegIFN/RBV or SOF/RBV treatment failures.
ombitasvir/abt-450/ritonavir
tablets
ribavirin
tablets

Primary Outcomes

Measure
Percentage of subjects with sustained virologic response 12 (SVR12) weeks post treatment
time frame: 12 weeks after the last actual dose of study drug
Percentage of subjects with treatment-emergent adverse events
time frame: Up to 30 days following end of treatment

Secondary Outcomes

Measure
Percentage of subjects with SVR12 in subjects receiving 12 weeks of treatment compared to subjects receiving 16 weeks of treatment.
time frame: 12 weeks after last actual dose of study drug
Percentage of subjects with on-treatment virologic failure
time frame: Up to 24 weeks after first dose of study drug
Percentage of subjects with post-treatment relapse
time frame: Within 12 weeks after the last dose of study drug
Percentage of subjects with SVR12 in subjects receiving 16 weeks of treatment compared to subjects receiving 24 weeks of treatment.
time frame: 12 weeks after last actual dose of study drug.

Eligibility Criteria

Male or female participants from 18 years up to 99 years old.

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.

Additional Information

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)
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AbbVie.