Phase 3 N=146 Treatment

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

Hepatitis C Virus Infection · Chronic Hepatitis C · Compensated Cirrhosis

Bottom Line

View on ClinicalTrials.gov: NCT02642432 ↗

Enrolled (actual)

146

Serious AEs

7.5%

Results posted

Sep 2017

Primary outcome: Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) — 99.3 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)	99.3	—
SECONDARY Percentage of Participants With On-treatment Virologic Failure	0.0	—
SECONDARY Percentage of Participants With Post-treatment Relapse	0.7	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02642432). 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.