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
For general inquiries, please contact
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
  • Hepatitis
  • Study Drug
  • Glecaprevir/Pibrentasvir
  • 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
    Showing {first} - {last} of {total} Results