Phase 3
N=104
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
Chronic Hepatitis C Virus (HCV) Infection
Bottom Line
View on ClinicalTrials.gov: NCT02651194 ↗Enrolled (actual)
104
Serious AEs
24.0%
Results posted
Oct 2017
Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 98.1 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ABT-493/ABT-530 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Oct 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) |
98.1 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Failure |
0.0 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0.0 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02651194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.