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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Virus

Treatments: Drug: ABT-493/ABT-530

Study type: Interventional

Funder types: Industry

Identifiers

NCT02636595

2015-002349-80 (EudraCT Number)

M13-583

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Screening laboratory result indicating hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.
2. Chronic HCV infection.
3. 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).
4. Non-cirrhotic participants.

Exclusion criteria

1. History of severe, life-threatening or other significant sensitivity to any excipient of the study drugs.
2. 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.
3. 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.
4. Positive test result at Screening for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus antibody (HIV Ab).
5. Co-infection with more than one HCV genotype.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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121 participants in 1 patient group

ABT-493/ABT-530

Experimental group

Description:

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Treatment:

Drug: ABT-493/ABT-530