NCT02243280

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

An Open-Label, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without Ribavirin in Subjects With Chronic Hepatitis C Virus (HCV) Genotype 1, 4, 5, and 6 Infection (SURVEYOR-I)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study consisted of two independent parts: Part 1 was conducted first followed by Part 2. Part 1 enrolled participants who received ABT-493 and ABT-530 for 12 weeks; Part 2 enrolled participants who received ABT-493 and ABT-530 for 8 or 12 weeks. Participants who completed or prematurely discontinued the treatment period were followed for 24 weeks to monitor HCV RNA to evaluate efficacy and the emergence and persistence of viral variants.

Conditions

• Chronic Hepatitis C
• Hepatitis C Virus
• HCV

Interventions

Type	Name	Description
DRUG	ABT-493	Tablet
DRUG	ABT-530	Tablet

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-09-17
• Last updated: 2021-07-13
• Results posted: 2017-04-06