A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection
Study Identifier
M16-156
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
Study Details
Medical Condition
Study Drug
Phase
Phase 3
Sex
Female & Male
Age
18+ years
Protocol Summary
This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV) genotype (GT) 1 to GT6 infection, without cirrhosis or with compensated cirrhosis, who were HCV treatment-naïve.
Study Locations
Location
Status
Location
Hospital Universitário Cassiano Antônio Moraes - HCUFES /ID# 163512
Vitória, Espírito Santo, Brazil, 29 043-260
Status
Not applicable
Location
Hospital Universitario da Universidade Federal do Maranhao - CEPEC /ID# 163169
São Luís, Maranhão, Brazil, 65045-040
Status
Not applicable
Location
Universidade Estadual de Maringá /ID# 166436
Maringá, Paraná, Brazil, 87083-068
Status
Not applicable
Location
Hospital de Clinicas de Porto Alegre /ID# 163166
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Not applicable
Location
Hospital de Clinicas de Porto Alegre /ID# 163167
Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
Status
Not applicable
Location
Hospital Ernesto Dornelles /ID# 163171
Porto Alegre, Rio Grande Do Sul, Brazil, 90160-093
Status
Not applicable
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