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
Study Identifier
M15-593
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
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Study Complete
Results Available
Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, Chinese (Simplified), Korean
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
18+ years
Protocol 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.
Study Locations
Location
Status
Location
Peking University Peoples Hospit /ID# 156851
Beijing, Beijing Municipality, China, 100044
Status
Not applicable
Location
Guangzhou Eighth People's Hosp /ID# 156865
Guangzhou, Guangdong, China, 510060
Status
Not applicable
Location
Guangdong General Hospital /ID# 156827
Guangzhou, Guangdong, China, 510080
Status
Not applicable
Location
Nanfang Hospital of Southern Medical University /ID# 156866
Guangzhou, Guangdong, China, 510515
Status
Not applicable
Location
The Third Affiliated Hospital Of Sun Yat-Sen University /ID# 156905
Guangzhou, Guangdong, China, 510630
Status
Not applicable
Location
The Second Hospital of Nanjing /ID# 156869
Nanjing, Jiangsu, China, 210003
Status
Not applicable
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