Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

Study Identifier
M20-350
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
Plain Language Summary
Available Language(s): English, German (Austria), French, German, Italian, Spanish
Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Hepatitis
  • Study Drug
  • Glecaprevir/Pibrentasvir (GLE/PIB)
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    12+ years

    Protocol Summary

    HCV infection is a global health problem. HCV mainly affects liver cells and causes the liver to become inflamed and damaged. This study will evaluate how safe and effective glecaprevir/pibrentasvir (GLE/PIB) is in adult and adolescent participants with acute HCV infection.

    GLE/PIB is an approved drug for the treatment of chronic HCV. Around 283 participants at least 12 years of age with acute HCV Infection will be enrolled in approximately 70 sites worldwide.

    Participants will receive oral tablets of GLE/PIB once daily (QD) for 8 weeks and will be followed for 12 weeks after the end of treatment.

    There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, monitoring for side effects and completing questionnaires.

    Study Locations

    Location
    Status
    Location
    Arizona Health Research /ID# 233558
    Chandler, Arizona, United States, 85225-2906
    Status
    Not applicable
    Location
    The Institute for Liver Health /ID# 228427
    Peoria, Arizona, United States, 85381
    Status
    Not applicable
    Location
    Liver Wellness Center /ID# 244933
    Little Rock, Arkansas, United States, 72204
    Status
    Not applicable
    Location
    AHF Research Center /ID# 254795
    Beverly Hills, California, United States, 90211
    Status
    Not applicable
    Location
    Velocity Clinical Research Chula Vista /ID# 238352
    Chula Vista, California, United States, 91911-6658
    Status
    Not applicable
    Location
    AHF Healthcare Center- Hollywood /ID# 254794
    Los Angeles, California, United States, 90027
    Status
    Not applicable
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