NCT02723084

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

A Randomized, Open-Label, Active Comparator, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus Infection (CERTAIN-2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this phase 3 study is to evaluate the efficacy and safety of ABT-493/ABT-530 in comparison to sofosbuvir plus ribavirin for 12 weeks in Hepatitis C Virus (HCV) Genotype 2 (GT2) infected participants.

Detailed description

This was a randomized, open-label, active-control, multicenter study to evaluate efficacy, safety, and pharmacokinetics of ABT-493/ABT-530 in chronic HCV GT2-infected direct-acting antiviral agent (DAA) treatment-naïve Japanese adult participants without cirrhosis. The participants were randomized in a 2:1 ratio to ABT-493/ABT-530 for 8 weeks (Arm A) and sofosbuvir plus ribavirin for 12 weeks (Arm B).

Conditions

• Chronic Hepatitis C Virus
• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	ABT-493/ABT-530	Co-formulated tablet
DRUG	sofosbuvir (SOF)	Tablet
DRUG	ribavirin (RBV)	Capsule

Timeline

• Start date: 2016-04-08
• Primary completion: 2017-01-19
• Completion: 2017-03-24
• First posted: 2016-03-30
• Last updated: 2021-07-16
• Results posted: 2019-02-15