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
Study Drug
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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