Overview

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.