A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus (HCV) Genotype 2 Infection (ENDURANCE-2)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C Virus (HCV) Infection

Treatments: Drug: ABT-493/ABT-530; Drug: Placebo for ABT-493/ABT-530

Study type: Interventional

Funder types: Industry

Identifiers

NCT02640482

2015-002348-14 (EudraCT Number)

M15-464

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of ABT-493/ABT-530 in adults with genotype 2 chronic hepatitis C virus (HCV) infection.

Enrollment: 304 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Screening laboratory result indicating hepatitis C virus (HCV) Genotype-2 (GT2) infection.
• Chronic HCV infection.
• Subject must be HCV treatment-naïve (subject had never received a single dose of any approved or investigational regimen) or had failed prior interferon (IFN) or pegylated-interferon (pegIFN) ± ribavirin (RBV) or sofosbuvir (SOF) + RBV ± pegIFN therapy.
• Subject must be non-cirrhotic.

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).
• HCV genotype performed during screening indicating coinfection with more than 1 HCV genotype.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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304 participants in 3 patient groups

Arm A DB Active Drug

Experimental group

Description:

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (double-blind \[DB\] treatment period)

Treatment:

Drug: ABT-493/ABT-530

Arm B DB Placebo

Experimental group

Description:

Placebo for ABT-493/ABT-530 QD for 12 weeks (DB treatment period)

Treatment:

Drug: Placebo for ABT-493/ABT-530

Arm B OL Active Drug

Experimental group

Description:

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks (open-label \[OL\] treatment period)

Treatment:

Drug: ABT-493/ABT-530