A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 an… (NCT02243280) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With HCV Genotype 1, 4, 5, and 6 Infection
174 participantsStarted 2014-08
Plain-language summary
The purpose of this Phase 2, open-label, 2-part, multicenter study was to evaluate the efficacy, safety, and pharmacokinetics of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) at different doses in chronic Hepatitis C virus (HCV) Genotype 1 (GT1), Genotype 4 (GT4), Genotype 5 (GT5), and Genotype 6 (GT6) infection with compensated cirrhosis (GT1 only) or without cirrhosis (GT1, GT4, GT5, or GT6). Although RBV was initially planned in the protocol, it was not administered in any of the study arms.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female between 18 and 70 years of age, inclusive, at time of screening
✓. Screening laboratory result indicating hepatitis C virus (HCV) GT1 (Study Parts 1 and 2) or GT4, GT5, or GT6 (Study Part 2) infection
✓. Chronic HCV infection defined as one of the following:
✓. Participant had to meet one of the following criteria:
✓. Documented absence of cirrhosis (in Study Part 1 and in corresponding arms of Study Part 2), or compensated cirrhosis (in corresponding arms of Study Part 2, GT1 only), per local standard
Exclusion criteria
✕. History of severe, life-threatening or other significant sensitivity to any 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)
✕. Hepatitis C virus (HCV) genotype performed during screening indicating co-infection with more than one HCV genotype
✕. Any cause of liver disease other than chronic HCV infection
What they're measuring
1
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks Post-treatment
Timeframe: 12 weeks after the last actual dose of study drug