A Study to Evaluate the Efficacy and Safety of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus Genotype 1 - 6 Infection and Renal Impairment

Study Identifier
M16-127
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
Scientific Result Summary
Available Language(s): English
Plain Language Summary
Available Language(s): English, German, Italian, Korean, Polish, Spanish

Study Details

Medical Condition
  • Hepatitis
  • Study Drug
  • Glecaprevir/pibrentasvir
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years

    Protocol Summary

    This was a Phase 3b, open-label, non-randomized, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir (GLE/PIB) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1 - 6 infection without liver cirrhosis or with compensated liver cirrhosis and with chronic renal impairment in participants who were either HCV treatment-naïve (TN) or prior treatment-experienced (TE) with interferon (IFN) or pegylated interferon (PegIFN) with or without ribavirin (RBV), or sofosbuvir (SOF) plus RBV with or without pegIFN.

    Study Locations

    Location
    Status
    Location
    Scripps Clinic /ID# 159116
    La Jolla, California, United States, 92037
    Status
    Not applicable
    Location
    Huntington Medical Foundation /ID# 160653
    Pasadena, California, United States, 91105
    Status
    Not applicable
    Location
    Tampa General Medical Group /ID# 159115
    Tampa, Florida, United States, 33606
    Status
    Not applicable
    Location
    Northwest Louisiana Nephrology /ID# 160652
    Shreveport, Louisiana, United States, 71101
    Status
    Not applicable
    Location
    Massachusetts General Hospital /ID# 159114
    Boston, Massachusetts, United States, 02114
    Status
    Not applicable
    Location
    North Shore University Hospital /ID# 159108
    New Hyde Park, New York, United States, 11040
    Status
    Not applicable
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