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)
NCT ID: NCT04903626
Last Updated: 2025-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
286 participants
INTERVENTIONAL
2021-08-24
2024-09-17
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Glecaprevir/Pibrentasvir
Participants treated once daily (QD) with glecaprevir/pibrentasvir 300 mg/120 mg for 8 weeks.
Glecaprevir/Pibrentasvir (GLE/PIB)
Oral tablets
Interventions
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Glecaprevir/Pibrentasvir (GLE/PIB)
Oral tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; OR
* Negative anti-HCV antibody, HCV RNA and/or HCV core antigen followed by a positive HCV RNA or HCV core antigen all within an 11-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to positive HCV RNA or HCV core antigen; OR
* Clinical signs and symptoms compatible with acute hepatitis \[alanine aminotransferase (ALT) \> 5 × upper limit of normal (ULN) and/or jaundice\] in the absence of a history of chronic liver disease or other cause of acute hepatitis and positive HCV RNA or HCV core antigen all within an 8-month period prior to screening; AND risk behavior for HCV infection within 6 months prior to 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 with indeterminate cirrhosis status, as indicated by a negative ultrasound, computed tomography (CT) scan or magnetic resonance imaging (MRI) within 3 months prior to screening or a negative ultrasound at screening. Participant who has a positive ultrasound result suspicious of HCC followed by a subsequent negative CT scan or MRI or biopsy result will be eligible for the study.
* Participants documented as having no cirrhosis or as having compensated cirrhosis.
Exclusion Criteria
* History of liver decompensation.
12 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Arizona Health Research /ID# 233558
Chandler, Arizona, United States
The Institute for Liver Health /ID# 228427
Peoria, Arizona, United States
Liver Wellness Center /ID# 244933
Little Rock, Arkansas, United States
AHF Research Center /ID# 254795
Beverly Hills, California, United States
Velocity Clinical Research Chula Vista /ID# 238352
Chula Vista, California, United States
AHF Healthcare Center- Hollywood /ID# 254794
Los Angeles, California, United States
TLC Clinical Research Inc /ID# 232334
Los Angeles, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 230814
Sacramento, California, United States
Angels Clinical Research Institute /ID# 234090
Doral, Florida, United States
AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814
Fort Lauderdale, Florida, United States
Midway Immunology and Research Center /ID# 229194
Ft. Pierce, Florida, United States
Midland Research Group, Inc /ID# 231885
Oakland Park, Florida, United States
Orlando Immunology Center /ID# 229839
Orlando, Florida, United States
Tampa General Hospital /ID# 228930
Tampa, Florida, United States
Duplicate_Triple O Research Institute /ID# 229928
West Palm Beach, Florida, United States
Florida Medical Clinic /ID# 233489
Zephyrhills, Florida, United States
Emory Midtown Infectious Disease Clinic /ID# 229927
Atlanta, Georgia, United States
University of Iowa Hospitals and Clinics /ID# 226934
Iowa City, Iowa, United States
Duplicate_University of Kentucky Chandler Medical Center /ID# 231588
Lexington, Kentucky, United States
University of Louisville Hospital /ID# 232139
Louisville, Kentucky, United States
Mercy Medical Center /ID# 226937
Baltimore, Maryland, United States
Johns Hopkins Hospital /ID# 230694
Baltimore, Maryland, United States
Henry Ford Hospital /ID# 226932
Detroit, Michigan, United States
University of Mississippi Medical Center /ID# 232620
Jackson, Mississippi, United States
Las Vegas Research Center /ID# 255631
Las Vegas, Nevada, United States
North Jersey Community Research Initiative (NJCRI) /ID# 245129
Newark, New Jersey, United States
Weill Cornell Medical College /ID# 230815
New York, New York, United States
Coastal Research Institute, LLC /ID# 233233
Fayetteville, North Carolina, United States
The Christ Hospital /ID# 231204
Cincinnati, Ohio, United States
Duplicate_University Of Cincinnati Medical Center /ID# 226922
Cincinnati, Ohio, United States
Cherokee Nation Outpatient Health Center /ID# 232618
Tahlequah, Oklahoma, United States
Thomas Jefferson University Hospital /ID# 232624
Philadelphia, Pennsylvania, United States
University Gastroenterology /ID# 233332
Providence, Rhode Island, United States
Vanderbilt University Medical Center /ID# 241282
Nashville, Tennessee, United States
Liver Associates of Texas, P.A /ID# 229775
Houston, Texas, United States
Digestive and Liver Disease Sp /ID# 232633
Norfolk, Virginia, United States
Wisconsin Medical Center /ID# 230116
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital /ID# 227167
Adelaide, South Australia, Australia
The Alfred Hospital /ID# 227169
Melbourne, Victoria, Australia
Universitaetsklinikum St. Poelten /ID# 227098
Sankt Pölten, Lower Austria, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985
Linz, Upper Austria, Austria
Medizinische Universitaet Wien /ID# 226938
Vienna, Vienna, Austria
Vancouver Infectious Diseases Centre /ID# 227125
Vancouver, British Columbia, Canada
CoolAid Medical Clinic /ID# 239978
Victoria, British Columbia, Canada
Charlton Medical Centre /ID# 228100
Hamilton, Ontario, Canada
Royal Victoria Hospital / McGill University Health Centre /ID# 227126
Montreal, Quebec, Canada
CHU Montpellier - Hopital Saint Eloi /ID# 229083
Montpellier, Herault, France
CH de Tourcoing /ID# 233732
Tourcoing, Nord, France
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 259111
Créteil, Paris, France
HCL - Hopital de la Croix-Rousse /ID# 229077
Lyon, Rhone, France
HCL - Hopital de la Croix-Rousse /ID# 259102
Lyon, Rhone, France
AP-HP - Hopital Saint-Antoine /ID# 229070
Paris, , France
Hopital Beaujon /ID# 246817
Clichy, Île-de-France Region, France
Infektiologikum /ID# 226880
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Bonn /ID# 226764
Bonn, North Rhine-Westphalia, Germany
Klinikum Dortmund gGmbH /ID# 249689
Dortmund, North Rhine-Westphalia, Germany
zibp-Zentrum fuer Infektiologie /ID# 226765
Berlin, , Germany
ICH Study Center GmbH & Co KG /ID# 228162
Hamburg, , Germany
Klinikum rechts der Isar /ID# 226783
Munich, , Germany
IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 227080
Bologna, Emilia-Romagna, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 227079
Milan, Milano, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 227183
Naples, Napoli, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078
Rome, Roma, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia /ID# 227081
Foggia, , Italy
Hospital Universitario Germans Trias i Pujol /ID# 226698
Badalona, Barcelona, Spain
Hospital Parc de Salut del Mar /ID# 226696
Barcelona, , Spain
Hospital Clinic de Barcelona /ID# 226695
Barcelona, , Spain
Centro Sanitario Sandoval /ID# 226954
Madrid, , Spain
Hospital Universitario Infanta Leonor /ID# 251780
Madrid, , Spain
Duplicate_Hospital General Universitario de Valencia /ID# 226709
Valencia, , Spain
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
Other Identifiers
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2020-005777-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M20-350
Identifier Type: -
Identifier Source: org_study_id
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