NCT03235349

Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection

An Open-Label Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cirrhosis with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) (alpha, beta or pegylated interferon \[pegIFN\]) with or without ribavirin (RBV) OR sofosbuvir with RBV with or without IFN.

Conditions

• Hepatitis C Virus (HCV)

Interventions

Type	Name	Description
DRUG	Glecaprevir/Pibrentasvir	Coformulated tablet for oral administration

Timeline

• Start date: 2017-09-29
• Primary completion: 2018-11-15
• Completion: 2019-02-25
• First posted: 2017-08-01
• Last updated: 2019-11-21
• Results posted: 2019-11-21

Locations

34 sites across 2 countries: China, South Korea