The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)

The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.

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Key information

Conditions

Hepatitis C Virus Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
Chronic HCV infection.
HCV treatment-naïve or treatment experienced (interferon [IFN] or pegylated interferon [pegIFN] with or without ribavirin [RBV]; sofosbuvir [SOF] plus RBV with or without pegIFN).
Non-cirrhotic participants.

Exclusion criteria

History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
Female who is pregnant, planning to become pregnant during the study, or breastfeeding; or male whose partner is pregnant or planning to become pregnant during the study.
Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol in the opinion of the investigator.
Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
Co-infection with more than one HCV genotype.

Treatment and study plan

ABT-493/ABT-530

Drug

Tablet; ABT-493 coformulated with ABT-530

Other names: ABT-493 also known as glecaprevir, ABT-530 also known as pibrentasvir, MAVYRET

Primary outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

Time frame: 12 weeks after the last actual dose of study drug

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.

Secondary outcomes

Percentage of Participants With On-treatment Virologic Failure

Time frame: Treatment weeks 1, 2, 4, 8, and 12 (end of treatment) or premature discontinuation from treatment

On-treatment virologic failure was defined as confirmed increase of > 1 log(subscript)10(subscript) IU/mL above the lowest value post-baseline HCV RNA during treatment; confirmed HCV RNA ≥ 100 IU/mL after HCV RNA < LLOQ during treatment, or HCV RNA ≥ LLOQ at end of treatment with at least 6 weeks of treatment.
Percentage of Participants With Post-treatment Relapse

Time frame: From the end of treatment through 12 weeks after the last dose of study drug

Post-treatment relapse was defined as confirmed HCV RNA ≥ LLOQ between the end of treatment and 12 weeks after the last dose of study drug among participants who completed treatment with HCV RNA levels < LLOQ at the end of treatment, excluding reinfection.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)

Acronym: ENDURANCE-4

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2017
First posted: Dec 22, 2015
Registry last updated: Jul 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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