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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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
  • Hepatitis
  • Study Drug
  • Glecaprevir/Pibrentasvir
  • 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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