A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis (EXPEDITION-1)

AbbVie

Status and phase: Completed; Phase 3

Conditions: Compensated Cirrhosis; Hepatitis C Virus Infection; Chronic Hepatitis C

Treatments: Drug: ABT-493/ABT-530

Study type: Interventional

Funder types: Industry

Identifiers

NCT02642432

2015-003797-32 (EudraCT Number)

M14-172

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection
• Chronic HCV infection
• Subject must be HCV treatment-naïve or have failed prior HCV treatment
• Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease

Exclusion criteria

• Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody
• HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype
• Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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146 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