A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Renally Impaired Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the efficacy and safety of 12 weeks of treatment with the ABT-493/ABT-530 combination regimen in adults with chronic HCV genotype 1 - 6 infection and chronic severe renal impairment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

Inclusion Criteria:

• Chronic hepatitis C virus (HCV) infection

• Screening laboratory results indicating HCV genotype 1 - 6 (GT1 - 6) infection.

• Subject must be HCV treatment-naïve or have failed previous HCV treatment.

• Subjects with underlying chronic renal impairment (estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 as estimated by the MDRD method at screening, including those requiring dialysis).

• Non-cirrhotic subjects must have documented absence of cirrhosis and subjects with cirrhosis must have documented compensated cirrhosis.

Exclusion Criteria:

• History of severe, life-threatening or other significant sensitivity to any excipients of the study drug.

• 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 co-infection with more than 1 HCV genotype; HCV GT3 infected, treatment-experienced subjects were excluded.

• Patients who failed a previous regimen containing protease inhibitor (PIs) and/or nonstructural protein 5A (NS5A) inhibitors.