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A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With or Without Human Immunodeficiency Virus Co-Infection
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in non-cirrhotic chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with or without human immunodeficiency virus (HIV) co-infection who are HCV treatment-naïve or treatment-experienced with interferon (IFN) with or without ribavirin (RBV), OR sofosbuvir with RBV with or without IFN.
Randomization was stratified by geographic region (China, South Korea, Singapore), genotype (GT1, GT2, combined GT3 - 6), and HCV/HIV co-infection status (co-infected, not co-infected). In China, eligible participants were randomized to Arm A or Arm B (defined below) in the following ratios: 2:1 for GT1, 2:1 for GT2, and 2:1 for combined GT3-6. In South Korea and Singapore, eligible participants were randomized to Arm A or Arm B in the following ratios: 2:1 for GT1 and 2:1 for GT2. All Primary and Secondary Outcome Measures were pre-specified to be analyzed only in Arm A.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Peking University Peoples Hospit /ID# 156846
Beijing, Beijing Municipality, China
Guangzhou Eighth People's Hosp /ID# 156859
Guangzhou, Guangdong, China
Guangdong General Hospital /ID# 156822
Guangzhou, Guangdong, China
Nanfang Hospital of Southern Medical University /ID# 156860
Guangzhou, Guangdong, China
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156900
Guangzhou, Guangdong, China
Xiangya Hospital Central South University /ID# 156901
Changsha, Hunan, China
The Second Hospital of Nanjing /ID# 156863
Nanjing, Jiangsu, China
Jiangsu Province People's Hospital /ID# 156861
Nanjing, Jiangsu, China
The First Hosp of Jilin Univ /ID# 156820
Changchun, Jilin, China
The Sixth People's Hospital of Shenyang /ID# 156849
Shenyang, Liaoning, China
Start Date
October 4, 2017
Primary Completion Date
October 18, 2018
Completion Date
February 15, 2019
Last Updated
December 23, 2019
546
ACTUAL participants
Placebo
DRUG
Glecaprevir/Pibrentasvir
DRUG
Lead Sponsor
AbbVie
NCT07388979
NCT02219490
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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