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)

Hepatitis C Virus Clinical Trial

— AGATE-1  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02265237
• Other study ID #: M11-665
• Secondary ID: 2014-001496-31
• Status: Completed
• Phase: Phase 3
• First received: October 10, 2014
• Last updated: April 25, 2017
• Start date: October 28, 2014
• Est. completion date: April 7, 2017

Study information

• Verified date: April 2017
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: April 7, 2017
• Est. primary completion date: May 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C Virus
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis

Intervention

Drug:
• ombitasvir/ABT-450/ritonavir
tablets
• Ribavirin
tablets

Locations

Country	Name	City	State
Austria	Site Reference ID/Investigator# 129623	Vienna
Austria	Site Reference ID/Investigator# 129624	Vienna
Austria	Site Reference ID/Investigator# 129625	Vienna
Belgium	Site Reference ID/Investigator# 129132	Brussels
Belgium	Site Reference ID/Investigator# 129134	Brussels
Belgium	Site Reference ID/Investigator# 129135	Brussels
Canada	Site Reference ID/Investigator# 129755	Toronto
Canada	Site Reference ID/Investigator# 129756	Toronto
Canada	Site Reference ID/Investigator# 129759	Vancouver
France	Site Reference ID/Investigator# 129522	Clichy
France	Site Reference ID/Investigator# 129523	Creteil
France	Site Reference ID/Investigator# 129518	Montpellier - Cedex 5
France	Site Reference ID/Investigator# 129519	Paris Cedex 14
France	Site Reference ID/Investigator# 129517	Pessac Cedex
Germany	Site Reference ID/Investigator# 129532	Berlin
Germany	Site Reference ID/Investigator# 129535	Frankfurt
Greece	Site Reference ID/Investigator# 129836	Athens
Greece	Site Reference ID/Investigator# 129838	Athens
Greece	Site Reference ID/Investigator# 129837	Rhodes
Italy	Site Reference ID/Investigator# 129530	Padua
Italy	Site Reference ID/Investigator# 129525	Parma
Italy	Site Reference ID/Investigator# 137354	Rozzano
Italy	Site Reference ID/Investigator# 129529	Turin
Spain	Site Reference ID/Investigator# 129619	Barcelona
Spain	Site Reference ID/Investigator# 129618	Madrid
Spain	Site Reference ID/Investigator# 129621	Majadahonda, Madrid
Spain	Site Reference ID/Investigator# 129675	Pontevedra
Spain	Site Reference ID/Investigator# 129616	Valencia
United States	Site Reference ID/Investigator# 135228	Baltimore	Maryland
United States	Site Reference ID/Investigator# 130045	Coronado	California

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Greece,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with sustained virologic response 12 (SVR12) weeks post treatment	Hepatitis C virus ribonucleic acid is less than the lower limit of quantification	12 weeks after the last actual dose of study drug
Primary	Percentage of subjects with treatment-emergent adverse events	Percentage of subjects who develop treatment-emergent adverse events	Up to 30 days following end of treatment
Secondary	Percentage of subjects with SVR12 in subjects receiving 12 weeks of treatment compared to subjects receiving 16 weeks of treatment.	Hepatitis C virus ribonucleic acid less than the lower limit of quantification	12 weeks after last actual dose of study drug
Secondary	Percentage of subjects with on-treatment virologic failure	Hepatitis C virus ribonucleic acid greater than lower limit of quantification	Up to 24 weeks after first dose of study drug
Secondary	Percentage of subjects with post-treatment relapse	Hepatitis C virus ribonucleic acid greater than lower limit of quantification	Within 12 weeks after the last dose of study drug
Secondary	Percentage of subjects with SVR12 in subjects receiving 16 weeks of treatment compared to subjects receiving 24 weeks of treatment.	Hepatitis C virus ribonucleic acid less than the lower limit of quantification	12 weeks after last actual dose of study drug.