Efficacy and Safety of 8-weeks of Glecaprevir/Pibrentasvir in Treatment-Naïve Adults With HCV Genotype 1-6 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤1

Study Identifier
M16-133
CT.gov Identifier
NCT03212521
EudraCT Identifier
2016-004876-23
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)
Plain Language Summary
Available Language(s): English, Bulgarian, German, Polish, Russian, Spanish
Download document(s)

Study Details

Medical Condition
  • Hepatitis
    • Study Drug
  • Glecaprevir/Pibrentasvir
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Inclusion Criteria: * Hepatitis C virus (HCV) genotype (GT) 1, 2, 3, 4, 5, or 6 infection. Mixed GT and indeterminate GT may be acceptable. * Aspartate aminotransferase (AST) to platelet ratio index (APRI) score of less than or equal to 1, at time of screening. * Does not have current active hepatitis B virus infection defined as: * positive hepatitis B surface antigen (HBsAg), OR * hepatitis B virus (HBV) deoxyribonucleic acid (DNA) \> lower limit of quantification (LLOQ) in subjects with isolated positive anti-hepatitis B core (HBc) (i.e., negative HBsAg and anti-hepatitis B surface\[HBs\]) * Platelets ≥ 150,000 cells/mm³ * Albumin ≥ lower limit of normal (LLN) * Positive anti-HCV antibody (Ab) AND plasma HCV ribonucleic acid (RNA) viral load ≥ 1,000 IU/mL at Screening and for at least 6 months before Screening. * No past history/evidence of cirrhosis. * No history of hepatocellular carcinoma. * Hepatitis C virus treatment-naïve (had not received a single dose of any approved or investigational anti-HCV medication). * If female, the subject must not be pregnant, breastfeeding, or considering becoming pregnant during the study and for 30 days after the last dose of study drug.

    Protocol Summary

    A study to evaluate the efficacy and safety of glecaprevir(GLE)/pibrentasvir(PIB) in treatment-naïve participants with chronic hepatitis C virus (HCV) genotypes 1-6 infection and with an aspartate aminotransferase to platelet ratio index (APRI) of less than or equal to 1.

    Study Locations

    Location
    Status
    Location
    Parkway Medical Center /ID# 161261
    Birmingham, Alabama, United States, 35215
    Status
    Not applicable
    Location
    Arkansas Gastroenterology /ID# 161266
    North Little Rock, Arkansas, United States, 72117
    Status
    Not applicable
    Location
    UC Davis Medical Center /ID# 161138
    Sacramento, California, United States, 95817
    Status
    Not applicable
    Location
    Yale University /ID# 161258
    New Haven, Connecticut, United States, 06510
    Status
    Not applicable
    Location
    Univ Maryland School Medicine /ID# 161157
    Baltimore, Maryland, United States, 21201
    Status
    Not applicable
    Location
    Digestive Disease Associates - Baltimore /ID# 161260
    Baltimore, Maryland, United States, 21229
    Status
    Not applicable
    Showing {first} - {last} of {total} Results