Clinical trial NCT03089944: A Study of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Official title: A Single Arm, Open-label Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment Naïve Adults With Chronic Hepatitis C Virus (HCV) Genotype 1-6 Infection and Compensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C Virus (HCV)
Keywords: Hepatitis C Virus (HCV)
Glecaprevir
Pibrentasvir
Treatment Naïve
Cirrhosis
Compensated Cirrhosis
Genotype (GT) 1-6
Pangenotypic
Chronic Hepatitis C Virus (HCV)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-03-24
Enrollment: 343
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A Phase 3b, single arm, open-label, multicenter study in treatment naïve adults with chronic HCV infection and compensated cirrhosis to assess the safety of 8 weeks of treatment with glecaprevir/pibrentasvir and to demonstrate the efficacy of the sustained virologic response 12 weeks post dosing (SVR12) rates of 8 weeks of treatment with glecaprevir/pibrentasvir compared to the historical SVR12 rates of 12 weeks of treatment with glecaprevir/pibrentasvir.


Eligibility criteria: Inclusion Criteria:

* Screening laboratory result indicating Hepatitis C Virus (HCV) Genotype (GT) 1-6 infection.
* 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:

* Female participant who is pregnant, breastfeeding or is considering becoming pregnant during the study, or for approximately 30 days after the last dose of study drug.
* 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.

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Hepatitis C Virus (HCV) Genotype (GT) 1,2,4,5 and 6-infected Participants in the Per Protocol (PP) Population
timeFrame: 12 weeks after last dose of study drug
measure: Percentage of Participants With SVR12 in HCV GT 1,2,4,5 and 6-infected Participants in the Intent-To-Treat (ITT) Population
timeFrame: 12 weeks after last dose of study drug
Secondary outcomes:
measure: Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the PP Population
timeFrame: 12 weeks after last dose of study drug
measure: Percentage of Participants With SVR12 in HCV GT1-6-infected Participants in the ITT Population
timeFrame: 12 weeks after the last dose of study drug
measure: Percentage of Participants With On-treatment Virologic Failure in the ITT Population
timeFrame: 8 weeks on treatment
measure: Percentage of Participants With Post-treatment Relapse
timeFrame: Up to 12 weeks after the last dose of study drug
measure: Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the PP Population
timeFrame: 12 weeks after the last dose of study drug
measure: Percentage of HCV GT3-infected Participants Who Achieved SVR12 in the ITT Population
timeFrame: 12 weeks after the last dose of study drug
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: St. Josephs Hosp and Med Ctr /ID# 162762
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic Arizona /ID# 162314
state: Arizona
city: Little Rock
country: United States
facility: Liver Wellness Center /ID# 162244
state: Arkansas
city: Bakersfield
country: United States
facility: Felizarta /ID# 162295
state: California
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System /ID# 162298
state: California
city: Los Angeles
country: United States
facility: Usc /Id# 162248
state: California
city: San Diego
country: United States
facility: Kaiser Permanente - San Diego (Palm Ave) /ID# 162289
state: California
city: Stanford
country: United States
facility: Stanford University School of Med /ID# 162209
state: California
city: West Hollywood
country: United States
facility: Cedars-Sinai Medical Center - West Hollywood /ID# 162313
state: California
city: Miami
country: United States
facility: University of Miami /ID# 162210
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute /ID# 162300
state: Florida
city: Atlanta
country: United States
facility: Piedmont Hospital /ID# 162646
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 162208
state: Illinois
city: Des Moines
country: United States
facility: Unity Point Health /ID# 162247
state: Iowa
city: Iowa City
country: United States
facility: The University of Iowa Hospita /ID# 162214
state: Iowa
city: Louisville
country: United States
facility: University of Louisville /ID# 162242
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana Research Ctr. LLC /ID# 162567
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center /ID# 162291
state: Maryland
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 162251
state: Minnesota
city: Jackson
country: United States
facility: Southern Therapy and Advanced Research (STAR) LLC /ID# 162241
state: Mississippi
city: Omaha
country: United States
facility: CHI Health Alegent Creighton /ID# 162286
state: Nebraska
city: Omaha
country: United States
facility: Univ Nebraska Med Ctr /ID# 162285
state: Nebraska
city: Newark
country: United States
facility: Rnjms /Id# 162213
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center /ID# 162312
state: New York
city: Bronx
country: United States
facility: James J. Peters VA Medical Center /ID# 162644
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College /ID# 161051
state: New York
city: New York
country: United States
facility: Icahn School of Med Mt. Sinai /ID# 162294
state: New York
city: Durham
country: United States
facility: Duke University Medical Center /ID# 162299
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Assoc /ID# 162212
state: North Carolina
city: Statesville
country: United States
facility: Carolinas Center for Liver Dis /ID# 162569
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland /ID# 162243
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic /ID# 162570
state: Ohio
city: Tulsa
country: United States
facility: Osuchs /Id# 162284
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Health Network /ID# 162603
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Center for Liver Diseases, Oakland /ID# 162568
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr /ID# 162211
state: Tennessee
city: Dallas
country: United States
facility: Texas Digestive Disease Consul /ID# 162648
state: Texas
city: Houston
country: United States
facility: University of Texas Health /ID# 162288
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth Univ /ID# 162215
state: Virginia
city: Madison
country: United States
facility: Univ of Wisconsin Hosp/Clinics /ID# 162645
state: Wisconsin
city: Sofia
country: Bulgaria
facility: Tokuda Hospital Sofia /ID# 163422
city: Sofia
country: Bulgaria
facility: DCC Fokus-5 - LZIP /ID# 163338
city: Sofia
country: Bulgaria
facility: Univ Hosp for Active Treat /ID# 163330
city: Sofia
country: Bulgaria
facility: UMHAT Sv. Ivan Rilski /ID# 163332
city: Calgary
country: Canada
facility: University of Calgary /ID# 161185
state: Alberta
city: Victoria
country: Canada
facility: Percuro Clinical Research, Ltd /ID# 161184
state: British Columbia
city: Halifax
country: Canada
facility: Qe Ii Hsc /Id# 161178
state: Nova Scotia
city: Ottawa
country: Canada
facility: The Ottawa Hospital Research /ID# 161179
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital /ID# 161182
state: Ontario
city: Plzen
country: Czechia
facility: Research Site s.r.o /ID# 163020
city: Prague
country: Czechia
facility: KlinMed s.r.o. /ID# 162893
city: Prague
country: Czechia
facility: Institut Klinicke a Experimeth /ID# 162900
city: Orleans CEDEX 2
country: France
facility: CHR Orleans - Hopital de la Source /ID# 163072
state: Centre-Val De Loire
city: TOULOUSE Cedex 9
country: France
facility: Hôpital Purpan /ID# 163065
state: Haute-Garonne
city: Amiens CEDEX 1
country: France
facility: CHU Amiens Picardie /ID# 163071
state: Somme
city: Clermont Ferrand
country: France
facility: CHU Estaing /ID# 163058
city: Creteil
country: France
facility: Hospital Henri Mondor /ID# 163061
city: Lyon
country: France
facility: Hopital de la Croix Rousse /ID# 163073
city: Athens
country: Greece
facility: General Hospital of Athens Laiko /ID# 162786
state: Attiki
city: Kifissia
country: Greece
facility: General and Oncology Hospital /ID# 162784
city: Larisa
country: Greece
facility: Reg Gen Univ Hosp Larissa /ID# 162783
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki /ID# 162785
city: Budapest
country: Hungary
facility: Budai Hepatologiai Centrum /ID# 166511
city: Budapest
country: Hungary
facility: Szent Janos Korhaz /ID# 166542
city: Dublin 8
country: Ireland
facility: St. James's Hospital /ID# 162619
state: Dublin
city: Dublin 4
country: Ireland
facility: St Vincent's Hospital /ID# 162617
city: Dublin
country: Ireland
facility: Beaumont Hospital /ID# 162618
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Ctr /ID# 162185
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rambam Health Care Campus /ID# 162023
city: Haifa
country: Israel
facility: The Lady Davis Carmel MC /ID# 162017
city: Ramat Gan
country: Israel
facility: Sheba Medical Center /ID# 162028
city: Napoli
country: Italy
facility: Universita della Campania Luigi Vanvitelli /ID# 162337
state: Campania
city: Bologna
country: Italy
facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 162335
state: Emilia-Romagna
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda /ID# 162340
state: Lombardia
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas /ID# 162336
state: Milano
city: Milan
country: Italy
facility: Polo Universitario Luigi Sacco /ID# 162339
city: Wrocław
country: Poland
facility: Centrum Badan Klinicznych, Przychodnia Badan Klinicznych /ID# 162760
state: Dolnoslaskie
city: Lublin
country: Poland
facility: HepID - Diagnostyka I Terapia /ID# 162761
state: Lubelskie
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczn /ID# 162757
city: Myslowice
country: Poland
facility: ID Clinic /ID# 162759
city: Lisbon
country: Portugal
facility: Centro Hosp de Lisboa Central /ID# 163770
state: Lisboa
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, EPE /ID# 163785
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto EPE /ID# 163765
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao /ID# 163766
city: Ponce
country: Puerto Rico
facility: GHGCPR Research Institute /ID# 162608
city: Ponce
country: Puerto Rico
facility: Instituto de Investigacion Cientifica del Sur /ID# 162566
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group /ID# 162565
city: Sector 2
country: Romania
facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 163484
state: Bucuresti
city: Sector 2
country: Romania
facility: Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 164449
state: Bucuresti
city: Sector 2
country: Romania
facility: Institutul Clinic Fundeni /ID# 163479
state: Bucuresti
city: Sector 2
country: Romania
facility: Institutul Clinic Fundeni /ID# 163500
state: Bucuresti
city: Bucuresti
country: Romania
facility: Institutul Nat. de Boli Infectioase /ID# 163488
city: Samara
country: Russian Federation
facility: LLC Medical Company Hepatolog /ID# 161998
state: Samarskaya Oblast
city: Moscow
country: Russian Federation
facility: CBSI Central scientific and research institute of epidemiology /ID# 161996
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital of R /ID# 163434
city: Stavropol
country: Russian Federation
facility: Stavropol State Medical Univ /ID# 161999
city: Tyumen
country: Russian Federation
facility: RSAHI Consulting and Diagnostic Centre /ID# 161995
city: Barcelona
country: Spain
facility: Hospital Parc de Salut del Mar /ID# 162198
city: Barcelona
country: Spain
facility: Hospital Univ Vall d'Hebron /ID# 162199
city: Cordoba
country: Spain
facility: Hospital Universitario Reina S /ID# 162200
city: Donostia
country: Spain
facility: Hospital Donostia /ID# 162197
city: Oviedo
country: Spain
facility: Hospital Univ Central Asturias /ID# 162195
city: Taichung City
country: Taiwan
facility: China Medical University Hosp /ID# 162950
state: Taichung
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 162949
city: Taipei City
country: Taiwan
facility: Taipei Veterans General Hosp /ID# 162776
city: Basildon
country: United Kingdom
facility: Basildon University Hospital /ID# 162616
state: Essex
city: London
country: United Kingdom
facility: The Royal Free Hospital /ID# 162614
state: London, City Of
city: Crumpsall
country: United Kingdom
facility: North Manchester General /ID# 163945
city: Edinburgh
country: United Kingdom
facility: Western General Hospital /ID# 162612
city: Nottinghamshire
country: United Kingdom
facility: Queens Medical Centre /ID# 162615
city: Hanoi
country: Vietnam
facility: National Hospital of Tropical Diseases /ID# 167974
city: Ho Chi Minh
country: Vietnam
facility: Hoa Hao Medic Co. Ltd. /ID# 168178
city: Ho Chi Minh
country: Vietnam
facility: Tropical Diseases Hospital /ID# 168211
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.