Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study

Study Identifier
M15-942
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Study Complete

Results Available

Protocol
Available Language(s): English
Statistical Analysis Plan
Available Language(s): English
Plain Language Summary
Available Language(s): English, Chinese (Simplified), German, Japanese, Russian, Spanish
Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Hepatitis
  • Study Drug
  • Sofosbuvir
  • Glecaprevir/Pibrentasvir
  • Ribavirin
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    12 - 99 Years

    Protocol Summary

    The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 - 6-infected participants (including non-cirrhotic, or cirrhotic with compensated cirrhosis participants) who had experienced virologic failure in an AbbVie parent clinical study.

    Study Locations

    Location
    Status
    Location
    Digestive Health Specialists of the Southeast /ID# 155719
    Dothan, Alabama, United States, 36305
    Status
    Not applicable
    Location
    Ruane Clinical Research Group /ID# 155714
    Los Angeles, California, United States, 90036
    Status
    Not applicable
    Location
    Digestive Disease Associates - Baltimore /ID# 155713
    Baltimore, Maryland, United States, 21229
    Status
    Not applicable
    Location
    Henry Ford Health System /ID# 155720
    Detroit, Michigan, United States, 48202
    Status
    Not applicable
    Location
    University of Buffalo /ID# 155721
    Buffalo, New York, United States, 14203
    Status
    Not applicable
    Location
    Carolinas Center For Liver Dis /ID# 155731
    Statesville, North Carolina, United States, 28677
    Status
    Not applicable
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