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)

Last updated: March 24, 2025
Sponsor: AbbVie
Overall Status: Completed

Phase

3

Condition

Hepatitis

Liver Disorders

Sexually Transmitted Diseases (Stds)

Treatment

Glecaprevir/Pibrentasvir (GLE/PIB)

Clinical Study ID

NCT04903626
M20-350
2020-005777-27
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Evidence of acute HCV infection prior to enrollment, defined as a physiciandiagnosis of acute HCV infection, quantifiable HCV ribonucleic Acid (RNA) atscreening, and at least 1 of the following:

  • Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by apositive HCV RNA or HCV core antigen all within an 8-month period prior toscreening; OR

  • Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by apositive HCV RNA or HCV core antigen all within an 11-month period prior toscreening; AND risk behavior for HCV infection within 6 months prior topositive HCV RNA or HCV core antigen; OR

  • Clinical signs and symptoms compatible with acute hepatitis [alanineaminotransferase (ALT) > 5 × upper limit of normal (ULN) and/or jaundice] inthe absence of a history of chronic liver disease or other cause of acutehepatitis and positive HCV RNA or HCV core antigen all within an 8-month periodprior to screening; AND risk behavior for HCV infection within 6 months priorto positive HCV RNA or HCV core antigen; OR

  • Negative anti-HCV antibody with a positive HCV RNA or HCV core antigen within a 5-month period prior to screening.

  • Absence of hepatocellular carcinoma (HCC), for participants with cirrhosis, or withindeterminate cirrhosis status, as indicated by a negative ultrasound, computedtomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior toscreening or a negative ultrasound at screening. Participant who has a positiveultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRIor biopsy result will be eligible for the study.

  • Participants documented as having no cirrhosis or as having compensated cirrhosis.

Exclusion

Exclusion Criteria:

  • Participants with prior treatment, including interferon for this HCV infection.

  • History of liver decompensation.

Study Design

Total Participants: 286
Treatment Group(s): 1
Primary Treatment: Glecaprevir/Pibrentasvir (GLE/PIB)
Phase: 3
Study Start date:
August 24, 2021
Estimated Completion Date:
September 17, 2024

Connect with a study center

  • Royal Adelaide Hospital /ID# 227167

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Alfred Health /ID# 227169

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • The Alfred Hospital /ID# 227169

    Melbourne, Victoria 3004
    Australia

    Site Not Available

  • Universitaetsklinikum St. Poelten /ID# 227098

    Sankt Poelten, Niederoesterreich 3100
    Austria

    Site Not Available

  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985

    Linz, Oberoesterreich 4010
    Austria

    Site Not Available

  • Medizinische Universitaet Wien /ID# 226938

    Vienna, Wien 1090
    Austria

    Site Not Available

  • Wilhelminenspital der Stadt Wien /ID# 227141

    Wien, 1160
    Austria

    Site Not Available

  • Vancouver Infectious Diseases Centre /ID# 227125

    Vancouver, British Columbia V6Z 2C7
    Canada

    Site Not Available

  • CoolAid Medical Clinic /ID# 239978

    Victoria, British Columbia V8W 1M8
    Canada

    Site Not Available

  • Charlton Medical Centre /ID# 228100

    Hamilton, Ontario L8N 1Y2
    Canada

    Site Not Available

  • South Riverdale Community Health Centre /ID# 228098

    Toronto, Ontario M4M 3P3
    Canada

    Site Not Available

  • Royal Victoria Hospital / McGill University Health Centre /ID# 227126

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • CHU Montpellier - Hopital Saint Eloi /ID# 229083

    Montpellier Cedex 5, Herault 34295
    France

    Site Not Available

  • CHU Montpellier - Hôpital Saint Eloi /ID# 229083

    Montpellier Cedex 5, Herault 34295
    France

    Site Not Available

  • Hopital Beaujon /ID# 246817

    Clichy, Ile-de-France 92110
    France

    Site Not Available

  • CH de Tourcoing /ID# 233732

    TOURCOING Cedex, Nord 59208
    France

    Site Not Available

  • Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 259111

    Creteil, Paris 94010
    France

    Site Not Available

  • HCL - Hopital de la Croix-Rousse /ID# 229077

    Lyon, Rhone 69004
    France

    Site Not Available

  • HCL - Hopital de la Croix-Rousse /ID# 259102

    Lyon, Rhone 69004
    France

    Site Not Available

  • Hopital Henri Mondor /ID# 259111

    Creteil, 94000
    France

    Site Not Available

  • Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 259111

    Créteil, 94010
    France

    Site Not Available

  • AP-HP - Hopital Saint-Antoine /ID# 229070

    Paris, 75012
    France

    Site Not Available

  • Infektiologikum /ID# 226880

    Frankfurt am Main, Hessen 60596
    Germany

    Site Not Available

  • Universitaetsklinikum Bonn /ID# 226764

    Bonn, Nordrhein-Westfalen 53127
    Germany

    Site Not Available

  • Klinikum Dortmund gGmbH /ID# 249689

    Dortmund, Nordrhein-Westfalen 44137
    Germany

    Site Not Available

  • zibp-Zentrum fuer Infektiologie /ID# 226765

    Berlin, 10439
    Germany

    Site Not Available

  • ICH Study Center GmbH & Co KG /ID# 228162

    Hamburg, 20146
    Germany

    Site Not Available

  • Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 226783

    Munich, 81675
    Germany

    Active - Recruiting

  • Klinikum rechts der Isar /ID# 226783

    Munich, 81675
    Germany

    Site Not Available

  • AOU Federico II /ID# 227183

    Naples, Campania 80131
    Italy

    Site Not Available

  • IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 227080

    Bologna, Emilia-Romagna 40138
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II /ID# 227183

    Napoli, L Aquila 80131
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 227079

    Milan, Milano 20162
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Federico II /ID# 227183

    Naples, Napoli 80131
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078

    Rome, Roma 00133
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 227080

    Bologna, 40138
    Italy

    Site Not Available

  • Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 227081

    Foggia, 71122
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia /ID# 227081

    Foggia, 71100
    Italy

    Site Not Available

  • ASST Grande Ospedale Metropolitano Niguarda /ID# 227079

    Milano, 20162
    Italy

    Site Not Available

  • Hospital Universitario Germans Trias i Pujol /ID# 226698

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Clinic de Barcelona /ID# 226695

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital Parc de Salut del Mar /ID# 226696

    Barcelona, 08003
    Spain

    Site Not Available

  • Centro Sanitario Sandoval /ID# 226954

    Madrid, 28010
    Spain

    Site Not Available

  • Hospital Universitario Infanta Leonor /ID# 251780

    Madrid, 28031
    Spain

    Site Not Available

  • Duplicate_Hospital General Universitario de Valencia /ID# 226709

    Valencia, 46014
    Spain

    Site Not Available

  • Hospital General Universitario de Valencia /ID# 226709

    Valencia, 46014
    Spain

    Completed

  • Arizona Health Research /ID# 233558

    Chandler, Arizona 85225-2906
    United States

    Site Not Available

  • The Institute for Liver Health /ID# 228427

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Laboratory Corporation of America Holdings /ID# 228427

    Phoenix, Arizona 85040-2969
    United States

    Site Not Available

  • Liver Wellness Center /ID# 244933

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • AHF Research Center /ID# 254795

    Beverly Hills, California 90211
    United States

    Site Not Available

  • Velocity Clinical Research Chula Vista /ID# 238352

    Chula Vista, California 91911-6658
    United States

    Site Not Available

  • AHF Healthcare Center- Hollywood /ID# 254794

    Los Angeles, California 90027
    United States

    Site Not Available

  • TLC Clinical Research Inc /ID# 232334

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California, Davis Comprehensive Cancer Center /ID# 230814

    Sacramento, California 95817
    United States

    Site Not Available

  • S California Liver Center /ID# 232336

    San Clemente, California 92673
    United States

    Site Not Available

  • Angels Clinical Research Institute /ID# 234090

    Doral, Florida 33122-1713
    United States

    Site Not Available

  • AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • AIDS Healthcare Foundation - Northpoint /ID# 254814

    Fort Lauderdale, Florida 33308
    United States

    Active - Recruiting

  • Midway Immunology and Research /ID# 229194

    Fort Pierce, Florida 34982
    United States

    Active - Recruiting

  • Midway Immunology and Research Center /ID# 229194

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • Midland Research Group, Inc /ID# 231885

    Oakland Park, Florida 33334-4434
    United States

    Site Not Available

  • Orlando Immunology Center /ID# 229839

    Orlando, Florida 32803
    United States

    Site Not Available

  • Tampa General Hospital /ID# 228930

    Tampa, Florida 33606
    United States

    Site Not Available

  • Duplicate_Triple O Research Institute /ID# 229928

    West Palm Beach, Florida 33407-3100
    United States

    Site Not Available

  • Triple O Research Institute /ID# 229928

    West Palm Beach, Florida 33407-3100
    United States

    Site Not Available

  • Florida Medical Clinic /ID# 233489

    Zephyrhills, Florida 33542
    United States

    Site Not Available

  • Emory Midtown Infectious Disease Clinic /ID# 229927

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Franciscan Health Munster /ID# 231618

    Munster, Indiana 46321-4037
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics /ID# 226934

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Duplicate_University of Kentucky Chandler Medical Center /ID# 231588

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Kentucky Chandler Medical Center /ID# 231588

    Lexington, Kentucky 40536
    United States

    Site Not Available

  • University of Louisville Hospital /ID# 232139

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Louisville Research Foundation Inc /ID# 232139

    Louisville, Kentucky 40202-1821
    United States

    Site Not Available

  • Johns Hopkins Hospital /ID# 230694

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Johns Hopkins University /ID# 230694

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Mercy Medical Center /ID# 226937

    Baltimore, Maryland 21202
    United States

    Site Not Available

  • UMass Memorial Medical Center /ID# 228442

    Worcester, Massachusetts 01655
    United States

    Site Not Available

  • Henry Ford Health System /ID# 226932

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Hospital /ID# 226932

    Detroit, Michigan 48202
    United States

    Site Not Available

  • University of Mississippi Medical Center /ID# 232620

    Jackson, Mississippi 39216-4500
    United States

    Site Not Available

  • Las Vegas Research Center /ID# 255631

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • North Jersey Community Research Initiative (NJCRI) /ID# 245129

    Newark, New Jersey 07103-2842
    United States

    Site Not Available

  • Erie County Medical Center /ID# 230184

    Buffalo, New York 14215
    United States

    Site Not Available

  • Weill Cornell Medical College /ID# 230815

    New York, New York 10065
    United States

    Site Not Available

  • Coastal Research Institute, LLC /ID# 233233

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Atrium Health - Huntersville /ID# 238365

    Huntersville, North Carolina 28078-7135
    United States

    Site Not Available

  • Duplicate_University Of Cincinnati Medical Center /ID# 226922

    Cincinnati, Ohio 45267-0585
    United States

    Site Not Available

  • The Christ Hospital /ID# 231204

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati /ID# 226922

    Cincinnati, Ohio 45267-0585
    United States

    Site Not Available

  • The Ohio State University /ID# 228484

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Cherokee Nation Outpatient Health Center /ID# 232618

    Tahlequah, Oklahoma 74464-0545
    United States

    Site Not Available

  • Thomas Jefferson University /ID# 232624

    Philadelphia, Pennsylvania 19107-4414
    United States

    Site Not Available

  • Thomas Jefferson University Hospital /ID# 232624

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Reading Hospital Clinical Trials Office /ID# 232622

    West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • University Gastroenterology /ID# 233332

    Providence, Rhode Island 02905
    United States

    Site Not Available

  • Vanderbilt University Medical Center /ID# 241282

    Nashville, Tennessee 37232-0011
    United States

    Site Not Available

  • Gadolin Research, LLC /ID# 233315

    Beaumont, Texas 77702-1100
    United States

    Site Not Available

  • Liver Associates of Texas, P.A /ID# 229775

    Houston, Texas 77030-2783
    United States

    Site Not Available

  • Digestive and Liver Disease Sp /ID# 232633

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Medical College of Wisconsin - Plank Rd /ID# 230116

    Milwaukee, Wisconsin 53226-3548
    United States

    Active - Recruiting

  • Wisconsin Medical Center /ID# 230116

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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