A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
NCT ID: NCT03089944
Last Updated: 2020-07-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
343 participants
INTERVENTIONAL
2017-04-28
2019-11-08
Brief Summary
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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 (GLE)/Pibrentasvir (PIB) for 8 weeks
Glecaprevir (GLE)/Pibrentasvir (PIB) 300 mg/120 mg once daily (QD) for 8 weeks.
Glecaprevir/Pibrentasvir
Tablet
Interventions
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Glecaprevir/Pibrentasvir
Tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive plasma HCV antibody and HCV RNA viral load greater than or equal to 1000 IU/mL at Screening.
* Treatment-naive to any approved or investigational anti-HCV medication.
* Participant must be documented as cirrhotic, with a Child-Pugh score of less than or equal to 6.
Exclusion Criteria
* Any current or historical clinical evidence of decompensated cirrhosis.
* Positive test result at Screening for hepatitis B surface antigen (HBsAg), HBV deoxyribonucleic acid \> lower limit of quantification (LLOQ) in subjects with isolated positive antibody to hepatitis B core antigen (anti-HBc) (i.e., negative HBsAg and anti-hepatitis B),or anti human immunodeficiency virus antibody (HIV Ab).
* HCV genotype performed by the central laboratory during screening indicating co-infection with more than one HCV genotype.
* History of suspected or confirmed hepatocellular carcinoma.
18 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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St. Josephs Hosp and Med Ctr /ID# 162762
Phoenix, Arizona, United States
Mayo Clinic Arizona /ID# 162314
Phoenix, Arizona, United States
Liver Wellness Center /ID# 162244
Little Rock, Arkansas, United States
Felizarta /ID# 162295
Bakersfield, California, United States
VA Long Beach Healthcare System /ID# 162298
Long Beach, California, United States
Usc /Id# 162248
Los Angeles, California, United States
Kaiser Permanente - San Diego (Palm Ave) /ID# 162289
San Diego, California, United States
Stanford University School of Med /ID# 162209
Stanford, California, United States
Cedars-Sinai Medical Center - West Hollywood /ID# 162313
West Hollywood, California, United States
University of Miami /ID# 162210
Miami, Florida, United States
Triple O Research Institute /ID# 162300
West Palm Beach, Florida, United States
Piedmont Hospital /ID# 162646
Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 162208
Chicago, Illinois, United States
Unity Point Health /ID# 162247
Des Moines, Iowa, United States
The University of Iowa Hospita /ID# 162214
Iowa City, Iowa, United States
University of Louisville /ID# 162242
Louisville, Kentucky, United States
Louisiana Research Ctr. LLC /ID# 162567
Shreveport, Louisiana, United States
Mercy Medical Center /ID# 162291
Baltimore, Maryland, United States
Mayo Clinic - Rochester /ID# 162251
Rochester, Minnesota, United States
Southern Therapy and Advanced Research (STAR) LLC /ID# 162241
Jackson, Mississippi, United States
CHI Health Alegent Creighton /ID# 162286
Omaha, Nebraska, United States
Univ Nebraska Med Ctr /ID# 162285
Omaha, Nebraska, United States
Rnjms /Id# 162213
Newark, New Jersey, United States
Weill Cornell Medical College /ID# 161051
New York, New York, United States
Icahn School of Med Mt. Sinai /ID# 162294
New York, New York, United States
Montefiore Medical Center /ID# 162312
The Bronx, New York, United States
James J. Peters VA Medical Center /ID# 162644
The Bronx, New York, United States
Duke University Medical Center /ID# 162299
Durham, North Carolina, United States
Cumberland Research Assoc /ID# 162212
Fayetteville, North Carolina, United States
Carolinas Center for Liver Dis /ID# 162569
Statesville, North Carolina, United States
University Hospitals Cleveland /ID# 162243
Cleveland, Ohio, United States
Cleveland Clinic /ID# 162570
Cleveland, Ohio, United States
Osuchs /Id# 162284
Tulsa, Oklahoma, United States
Lehigh Valley Health Network /ID# 162603
Allentown, Pennsylvania, United States
Center for Liver Diseases, Oakland /ID# 162568
Pittsburgh, Pennsylvania, United States
Vanderbilt Univ Med Ctr /ID# 162211
Nashville, Tennessee, United States
Texas Digestive Disease Consul /ID# 162648
Dallas, Texas, United States
University of Texas Health /ID# 162288
Houston, Texas, United States
Virginia Commonwealth Univ /ID# 162215
Richmond, Virginia, United States
Univ of Wisconsin Hosp/Clinics /ID# 162645
Madison, Wisconsin, United States
Tokuda Hospital Sofia /ID# 163422
Sofia, , Bulgaria
DCC Fokus-5 - LZIP /ID# 163338
Sofia, , Bulgaria
Univ Hosp for Active Treat /ID# 163330
Sofia, , Bulgaria
UMHAT Sv. Ivan Rilski /ID# 163332
Sofia, , Bulgaria
University of Calgary /ID# 161185
Calgary, Alberta, Canada
Percuro Clinical Research, Ltd /ID# 161184
Victoria, British Columbia, Canada
Qe Ii Hsc /Id# 161178
Halifax, Nova Scotia, Canada
The Ottawa Hospital Research /ID# 161179
Ottawa, Ontario, Canada
Toronto General Hospital /ID# 161182
Toronto, Ontario, Canada
Research Site s.r.o /ID# 163020
Pilsen, , Czechia
KlinMed s.r.o. /ID# 162893
Prague, , Czechia
Institut Klinicke a Experimeth /ID# 162900
Prague, , Czechia
CHR Orleans - Hopital de la Source /ID# 163072
Orléans, Centre-Val de Loire, France
Hôpital Purpan /ID# 163065
Toulouse, Haute-Garonne, France
CHU Amiens Picardie /ID# 163071
Amiens, Somme, France
CHU Estaing /ID# 163058
Clermont-Ferrand, , France
Hospital Henri Mondor /ID# 163061
Créteil, , France
Hopital de la Croix Rousse /ID# 163073
Lyon, , France
General Hospital of Athens Laiko /ID# 162786
Athens, Attica, Greece
General and Oncology Hospital /ID# 162784
Kifissia, , Greece
Reg Gen Univ Hosp Larissa /ID# 162783
Larissa, , Greece
Bioclinic Thessaloniki /ID# 162785
Thessaloniki, , Greece
Budai Hepatologiai Centrum /ID# 166511
Budapest, , Hungary
Szent Janos Korhaz /ID# 166542
Budapest, , Hungary
St. James's Hospital /ID# 162619
Dublin, Dublin, Ireland
Beaumont Hospital /ID# 162618
Dublin, , Ireland
St Vincent's Hospital /ID# 162617
Dublin, , Ireland
Tel Aviv Sourasky Medical Ctr /ID# 162185
Tel Aviv, Tel Aviv, Israel
Rambam Health Care Campus /ID# 162023
Haifa, , Israel
The Lady Davis Carmel MC /ID# 162017
Haifa, , Israel
Sheba Medical Center /ID# 162028
Ramat Gan, , Israel
Universita della Campania Luigi Vanvitelli /ID# 162337
Napoli, Campania, Italy
A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335
Bologna, Emilia-Romagna, Italy
ASST Grande Ospedale Metropolitano Niguarda /ID# 162340
Milan, Lombardy, Italy
Istituto Clinico Humanitas /ID# 162336
Rozzano, Milano, Italy
Polo Universitario Luigi Sacco /ID# 162339
Milan, , Italy
Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760
Wroclaw, Lower Silesian Voivodeship, Poland
HepID - Diagnostyka I Terapia /ID# 162761
Lublin, Lublin Voivodeship, Poland
Uniwersytecki Szpital Kliniczn /ID# 162757
Bialystok, , Poland
ID Clinic /ID# 162759
Mysłowice, , Poland
Centro Hosp de Lisboa Central /ID# 163770
Lisbon, Lisbon District, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 163785
Lisbon, , Portugal
Centro Hospitalar do Porto EPE /ID# 163765
Porto, , Portugal
Centro Hospitalar de Sao Joao /ID# 163766
Porto, , Portugal
GHGCPR Research Institute /ID# 162608
Ponce, , Puerto Rico
Instituto de Investigacion Cientifica del Sur /ID# 162566
Ponce, , Puerto Rico
Klinical Investigations Group /ID# 162565
San Juan, , Puerto Rico
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484
Sector 2, București, Romania
Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449
Sector 2, București, Romania
Institutul Clinic Fundeni /ID# 163479
Sector 2, București, Romania
Institutul Clinic Fundeni /ID# 163500
Sector 2, București, Romania
Institutul Nat. de Boli Infectioase /ID# 163488
Bucharest, , Romania
LLC Medical Company Hepatolog /ID# 161998
Samara, Samara Oblast, Russia
CBSI Central scientific and research institute of epidemiology /ID# 161996
Moscow, , Russia
Central Clinical Hospital of R /ID# 163434
Moscow, , Russia
Stavropol State Medical Univ /ID# 161999
Stavropol, , Russia
RSAHI Consulting and Diagnostic Centre /ID# 161995
Tyumen, , Russia
Hospital Parc de Salut del Mar /ID# 162198
Barcelona, , Spain
Hospital Univ Vall d'Hebron /ID# 162199
Barcelona, , Spain
Hospital Universitario Reina S /ID# 162200
Córdoba, , Spain
Hospital Donostia /ID# 162197
Donostia / San Sebastian, , Spain
Hospital Univ Central Asturias /ID# 162195
Oviedo, , Spain
China Medical University Hosp /ID# 162950
Taichung, Taichung, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949
Kaohsiung City, , Taiwan
Taipei Veterans General Hosp /ID# 162776
Taipei, , Taiwan
Basildon University Hospital /ID# 162616
Basildon, Essex, United Kingdom
The Royal Free Hospital /ID# 162614
London, London, City of, United Kingdom
North Manchester General /ID# 163945
Crumpsall, , United Kingdom
Western General Hospital /ID# 162612
Edinburgh, , United Kingdom
Queens Medical Centre /ID# 162615
Nottinghamshire, , United Kingdom
National Hospital of Tropical Diseases /ID# 167974
Hanoi, , Vietnam
Hoa Hao Medic Co. Ltd. /ID# 168178
Ho Chi Minh City, , Vietnam
Tropical Diseases Hospital /ID# 168211
Ho Chi Minh City, , Vietnam
Countries
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References
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Brown RS Jr, Buti M, Rodrigues L, Chulanov V, Chuang WL, Aguilar H, Horvath G, Zuckerman E, Carrion BR, Rodriguez-Perez F, Urbanek P, Abergel A, Cohen E, Lovell SS, Schnell G, Lin CW, Zha J, Wang S, Trinh R, Mensa FJ, Burroughs M, Felizarta F. Glecaprevir/pibrentasvir for 8 weeks in treatment-naive patients with chronic HCV genotypes 1-6 and compensated cirrhosis: The EXPEDITION-8 trial. J Hepatol. 2020 Mar;72(3):441-449. doi: 10.1016/j.jhep.2019.10.020. Epub 2019 Nov 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-004967-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M16-135
Identifier Type: -
Identifier Source: org_study_id
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