Phase 3 N=302 Randomized Double-blind Treatment

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

Chronic Hepatitis C Virus (HCV) Infection

Bottom Line

View on ClinicalTrials.gov: NCT02640482 ↗

Enrolled (actual)

302

Serious AEs

1.2%

Results posted

Sep 2017

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Noninferiority Analysis — 99.5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: ABT-493/ABT-530 (Drug); Placebo for ABT-493/ABT-530 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: AbbVie
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Noninferiority Analysis	99.5	—
SECONDARY Percentage of Participants With SVR12 in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures: Superiority Analysis	99.5	—
SECONDARY Percentage of Participants With On-treatment Virologic Failure in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures	0.0	—
SECONDARY Percentage of Participants With Post-treatment Relapse in Arm A DB Active Drug Excluding Prior SOF + Ribavirin (RBV) ± pegIFN Failures	0.0	—
SECONDARY Percentage of Participants With SVR12 in Arm A DB Active Drug With Prior SOF + RBV ± pegIFN Failure	100	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02640482). 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.