Phase
Condition
Hepatitis
Liver Disorders
Sexually Transmitted Diseases (Stds)
Treatment
Glecaprevir/Pibrentasvir (GLE/PIB)
Clinical Study ID
Ages > 12 All Genders
Study Summary
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
Connect with a study center
Royal Adelaide Hospital /ID# 227167
Adelaide, South Australia 5000
AustraliaSite Not Available
Alfred Health /ID# 227169
Melbourne, Victoria 3004
AustraliaSite Not Available
The Alfred Hospital /ID# 227169
Melbourne, Victoria 3004
AustraliaSite Not Available
Universitaetsklinikum St. Poelten /ID# 227098
Sankt Poelten, Niederoesterreich 3100
AustriaSite Not Available
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 226985
Linz, Oberoesterreich 4010
AustriaSite Not Available
Medizinische Universitaet Wien /ID# 226938
Vienna, Wien 1090
AustriaSite Not Available
Wilhelminenspital der Stadt Wien /ID# 227141
Wien, 1160
AustriaSite Not Available
Vancouver Infectious Diseases Centre /ID# 227125
Vancouver, British Columbia V6Z 2C7
CanadaSite Not Available
CoolAid Medical Clinic /ID# 239978
Victoria, British Columbia V8W 1M8
CanadaSite Not Available
Charlton Medical Centre /ID# 228100
Hamilton, Ontario L8N 1Y2
CanadaSite Not Available
South Riverdale Community Health Centre /ID# 228098
Toronto, Ontario M4M 3P3
CanadaSite Not Available
Royal Victoria Hospital / McGill University Health Centre /ID# 227126
Montreal, Quebec H4A 3J1
CanadaSite Not Available
CHU Montpellier - Hopital Saint Eloi /ID# 229083
Montpellier Cedex 5, Herault 34295
FranceSite Not Available
CHU Montpellier - Hôpital Saint Eloi /ID# 229083
Montpellier Cedex 5, Herault 34295
FranceSite Not Available
Hopital Beaujon /ID# 246817
Clichy, Ile-de-France 92110
FranceSite Not Available
CH de Tourcoing /ID# 233732
TOURCOING Cedex, Nord 59208
FranceSite Not Available
Hopitaux Universitaires Henri Mondor - Hopital Henri Mondor /ID# 259111
Creteil, Paris 94010
FranceSite Not Available
HCL - Hopital de la Croix-Rousse /ID# 229077
Lyon, Rhone 69004
FranceSite Not Available
HCL - Hopital de la Croix-Rousse /ID# 259102
Lyon, Rhone 69004
FranceSite Not Available
Hopital Henri Mondor /ID# 259111
Creteil, 94000
FranceSite Not Available
Hôpitaux Universitaires Henri Mondor - Hôpital Henri Mondor /ID# 259111
Créteil, 94010
FranceSite Not Available
AP-HP - Hopital Saint-Antoine /ID# 229070
Paris, 75012
FranceSite Not Available
Infektiologikum /ID# 226880
Frankfurt am Main, Hessen 60596
GermanySite Not Available
Universitaetsklinikum Bonn /ID# 226764
Bonn, Nordrhein-Westfalen 53127
GermanySite Not Available
Klinikum Dortmund gGmbH /ID# 249689
Dortmund, Nordrhein-Westfalen 44137
GermanySite Not Available
zibp-Zentrum fuer Infektiologie /ID# 226765
Berlin, 10439
GermanySite Not Available
ICH Study Center GmbH & Co KG /ID# 228162
Hamburg, 20146
GermanySite Not Available
Klinikum rechts der Isar - Technische Universitaet Muenchen /ID# 226783
Munich, 81675
GermanyActive - Recruiting
Klinikum rechts der Isar /ID# 226783
Munich, 81675
GermanySite Not Available
AOU Federico II /ID# 227183
Naples, Campania 80131
ItalySite Not Available
IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 227080
Bologna, Emilia-Romagna 40138
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II /ID# 227183
Napoli, L Aquila 80131
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda /ID# 227079
Milan, Milano 20162
ItalySite Not Available
Azienda Ospedaliera Universitaria Federico II /ID# 227183
Naples, Napoli 80131
ItalySite Not Available
Azienda Ospedaliera Universitaria Policlinico Tor Vergata /ID# 227078
Rome, Roma 00133
ItalySite Not Available
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 227080
Bologna, 40138
ItalySite Not Available
Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 227081
Foggia, 71122
ItalySite Not Available
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia /ID# 227081
Foggia, 71100
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda /ID# 227079
Milano, 20162
ItalySite Not Available
Hospital Universitario Germans Trias i Pujol /ID# 226698
Badalona, Barcelona 08916
SpainSite Not Available
Hospital Clinic de Barcelona /ID# 226695
Barcelona, 08036
SpainSite Not Available
Hospital Parc de Salut del Mar /ID# 226696
Barcelona, 08003
SpainSite Not Available
Centro Sanitario Sandoval /ID# 226954
Madrid, 28010
SpainSite Not Available
Hospital Universitario Infanta Leonor /ID# 251780
Madrid, 28031
SpainSite Not Available
Duplicate_Hospital General Universitario de Valencia /ID# 226709
Valencia, 46014
SpainSite Not Available
Hospital General Universitario de Valencia /ID# 226709
Valencia, 46014
SpainCompleted
Arizona Health Research /ID# 233558
Chandler, Arizona 85225-2906
United StatesSite Not Available
The Institute for Liver Health /ID# 228427
Peoria, Arizona 85381
United StatesSite Not Available
Laboratory Corporation of America Holdings /ID# 228427
Phoenix, Arizona 85040-2969
United StatesSite Not Available
Liver Wellness Center /ID# 244933
Little Rock, Arkansas 72204
United StatesSite Not Available
AHF Research Center /ID# 254795
Beverly Hills, California 90211
United StatesSite Not Available
Velocity Clinical Research Chula Vista /ID# 238352
Chula Vista, California 91911-6658
United StatesSite Not Available
AHF Healthcare Center- Hollywood /ID# 254794
Los Angeles, California 90027
United StatesSite Not Available
TLC Clinical Research Inc /ID# 232334
Los Angeles, California 90048
United StatesSite Not Available
University of California, Davis Comprehensive Cancer Center /ID# 230814
Sacramento, California 95817
United StatesSite Not Available
S California Liver Center /ID# 232336
San Clemente, California 92673
United StatesSite Not Available
Angels Clinical Research Institute /ID# 234090
Doral, Florida 33122-1713
United StatesSite Not Available
AIDS Healthcare Foundation (AHF) - Healthcare Center - Northpoint /ID# 254814
Fort Lauderdale, Florida 33308
United StatesSite Not Available
AIDS Healthcare Foundation - Northpoint /ID# 254814
Fort Lauderdale, Florida 33308
United StatesActive - Recruiting
Midway Immunology and Research /ID# 229194
Fort Pierce, Florida 34982
United StatesActive - Recruiting
Midway Immunology and Research Center /ID# 229194
Fort Pierce, Florida 34982
United StatesSite Not Available
Midland Research Group, Inc /ID# 231885
Oakland Park, Florida 33334-4434
United StatesSite Not Available
Orlando Immunology Center /ID# 229839
Orlando, Florida 32803
United StatesSite Not Available
Tampa General Hospital /ID# 228930
Tampa, Florida 33606
United StatesSite Not Available
Duplicate_Triple O Research Institute /ID# 229928
West Palm Beach, Florida 33407-3100
United StatesSite Not Available
Triple O Research Institute /ID# 229928
West Palm Beach, Florida 33407-3100
United StatesSite Not Available
Florida Medical Clinic /ID# 233489
Zephyrhills, Florida 33542
United StatesSite Not Available
Emory Midtown Infectious Disease Clinic /ID# 229927
Atlanta, Georgia 30322
United StatesSite Not Available
Franciscan Health Munster /ID# 231618
Munster, Indiana 46321-4037
United StatesSite Not Available
University of Iowa Hospitals and Clinics /ID# 226934
Iowa City, Iowa 52242
United StatesSite Not Available
Duplicate_University of Kentucky Chandler Medical Center /ID# 231588
Lexington, Kentucky 40536
United StatesSite Not Available
University of Kentucky Chandler Medical Center /ID# 231588
Lexington, Kentucky 40536
United StatesSite Not Available
University of Louisville Hospital /ID# 232139
Louisville, Kentucky 40202
United StatesSite Not Available
University of Louisville Research Foundation Inc /ID# 232139
Louisville, Kentucky 40202-1821
United StatesSite Not Available
Johns Hopkins Hospital /ID# 230694
Baltimore, Maryland 21287
United StatesSite Not Available
Johns Hopkins University /ID# 230694
Baltimore, Maryland 21287
United StatesActive - Recruiting
Mercy Medical Center /ID# 226937
Baltimore, Maryland 21202
United StatesSite Not Available
UMass Memorial Medical Center /ID# 228442
Worcester, Massachusetts 01655
United StatesSite Not Available
Henry Ford Health System /ID# 226932
Detroit, Michigan 48202
United StatesSite Not Available
Henry Ford Hospital /ID# 226932
Detroit, Michigan 48202
United StatesSite Not Available
University of Mississippi Medical Center /ID# 232620
Jackson, Mississippi 39216-4500
United StatesSite Not Available
Las Vegas Research Center /ID# 255631
Las Vegas, Nevada 89106
United StatesSite Not Available
North Jersey Community Research Initiative (NJCRI) /ID# 245129
Newark, New Jersey 07103-2842
United StatesSite Not Available
Erie County Medical Center /ID# 230184
Buffalo, New York 14215
United StatesSite Not Available
Weill Cornell Medical College /ID# 230815
New York, New York 10065
United StatesSite Not Available
Coastal Research Institute, LLC /ID# 233233
Fayetteville, North Carolina 28304
United StatesSite Not Available
Atrium Health - Huntersville /ID# 238365
Huntersville, North Carolina 28078-7135
United StatesSite Not Available
Duplicate_University Of Cincinnati Medical Center /ID# 226922
Cincinnati, Ohio 45267-0585
United StatesSite Not Available
The Christ Hospital /ID# 231204
Cincinnati, Ohio 45219
United StatesSite Not Available
University of Cincinnati /ID# 226922
Cincinnati, Ohio 45267-0585
United StatesSite Not Available
The Ohio State University /ID# 228484
Columbus, Ohio 43210
United StatesSite Not Available
Cherokee Nation Outpatient Health Center /ID# 232618
Tahlequah, Oklahoma 74464-0545
United StatesSite Not Available
Thomas Jefferson University /ID# 232624
Philadelphia, Pennsylvania 19107-4414
United StatesSite Not Available
Thomas Jefferson University Hospital /ID# 232624
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Reading Hospital Clinical Trials Office /ID# 232622
West Reading, Pennsylvania 19611
United StatesSite Not Available
University Gastroenterology /ID# 233332
Providence, Rhode Island 02905
United StatesSite Not Available
Vanderbilt University Medical Center /ID# 241282
Nashville, Tennessee 37232-0011
United StatesSite Not Available
Gadolin Research, LLC /ID# 233315
Beaumont, Texas 77702-1100
United StatesSite Not Available
Liver Associates of Texas, P.A /ID# 229775
Houston, Texas 77030-2783
United StatesSite Not Available
Digestive and Liver Disease Sp /ID# 232633
Norfolk, Virginia 23502
United StatesSite Not Available
Medical College of Wisconsin - Plank Rd /ID# 230116
Milwaukee, Wisconsin 53226-3548
United StatesActive - Recruiting
Wisconsin Medical Center /ID# 230116
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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