Clinical trial NCT03053063: Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Nonalcoholic Steatohepatitis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2017-02-14
Enrollment: 883
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.


Eligibility criteria: Key Inclusion Criteria:

* Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH Clinical Research Network (CRN) classification, in the opinion of the central reader
* Has the following laboratory parameters at the screening visit, as determined by the central laboratory:

  * Alanine aminotransferase (ALT) ≤ 8 x upper limit of normal (ULN)
  * Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
  * HbA1c ≤ 9.5% (or serum fructosamine ≤ 381 micromole (μmol) if HbA1c is unable to be resulted)
  * International normalised ratio (INR) ≤ 1.4, unless due to therapeutic anti-coagulation
  * Platelet count ≥ 100,000/μL

Key Exclusion Criteria:

* Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
* Child-Pugh (CP) score \> 7, as determined at screening, unless due to therapeutic anti-coagulation
* Model for End-stage Liver Disease (MELD) score \> 12, as determined at screening, unless due to therapeutic anti-coagulation
* Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history and/or centralized review of liver histology.
* History of liver transplantation
* Current or history of hepatocellular carcinoma (HCC)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Percentage of Participants Who Achieve a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH
timeFrame: Week 48
measure: Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event
timeFrame: Week 240
Secondary outcomes:
measure: Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240
timeFrame: Week 240
measure: Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48
timeFrame: Week 48
measure: Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240
timeFrame: Week 240
measure: Percentage of Participants Who Had NASH Resolution at Week 48
timeFrame: Week 48
measure: Percentage of Participants Who Had NASH Resolution at Week 240
timeFrame: Week 240
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Institute of Liver Health
state: Arizona
city: Phoenix
country: United States
facility: St. Joseph's Hospital and Medical Center
state: Arizona
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Little Rock
country: United States
facility: Baptist Medical Center
state: Arkansas
city: North Little Rock
country: United States
facility: Arkansas Gastroenterology
state: Arkansas
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Fresno
country: United States
facility: Fresno Clinical Research Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinical Research Services
state: California
city: La Jolla
country: United States
facility: University of California, San Diego (Altman Clinical and Translational Research Center)
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center
state: California
city: Pasadena
country: United States
facility: California Liver Research Institute
state: California
city: Pasadena
country: United States
facility: Huntington Medical Research Institutes (HMRI) Liver Center
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Diego
country: United States
facility: Research and Education, Inc.
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant
state: California
city: San Francisco
country: United States
facility: eStudySite
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco-Liver Clinic
state: California
city: Ventura
country: United States
facility: Island View Gastroenterology Associates- Ventura
state: California
city: Aurora
country: United States
facility: University of Colorado Denver and Hospital
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology, PC
state: Colorado
city: Doral
country: United States
facility: Integrity Clinical Research, LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida Hepatology Research at CTRB
state: Florida
city: Homestead
country: United States
facility: Clinical Research of Homestead
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases/University of Miami
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Transplant Institute
state: Florida
city: Palmetto
country: United States
facility: IMIC Inc
state: Florida
city: Wellington
country: United States
facility: South Florida Center of Gastroenterology, PA
state: Florida
city: Weston
country: United States
facility: Cleveland Clinic Florida
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, PA
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Transplant Institute
state: Georgia
city: Columbus
country: United States
facility: Columbus Regional Research Institute
state: Georgia
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia, PC
state: Georgia
city: Chicago
country: United States
facility: Northwestern Memorial Hospital; Clinical Research Unit
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago Medical Center
state: Illinois
city: Glenview
country: United States
facility: NorthShore University HealthSystem - Glenbrook ACC
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health - University Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indianapolis Gastroenterology Research Foundation
state: Indiana
city: Clive
country: United States
facility: Iowa Digestive Disease Center, P.C.
state: Iowa
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Hazard
country: United States
facility: Gastroenterology Associates of Hazard
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville Clinical Trials Unit
state: Kentucky
city: Bastrop
country: United States
facility: Delta Research Partners
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Health Sciences Center
state: Louisiana
city: New Orleans
country: United States
facility: Ocshner Medical Center
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Catonsville
country: United States
facility: Digestive Disease Associates, PA
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, P.L.C.
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Ridgeland
country: United States
facility: Southern Therapy and Advanced Research LLC (STAR)
state: Mississippi
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Newark
country: United States
facility: Rutgers New Jersey Medical School- Doctors Office Center
state: New Jersey
city: Albuquerque
country: United States
facility: AccumetRx Clinical Research
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Buffalo
country: United States
facility: University of Buffalo, Clinical and Translational Research Center
state: New York
city: Manhasset
country: United States
facility: Northwell Health - Sandra Atlas Bass Center for Liver Diseases
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai Beth Israel
state: New York
city: New York
country: United States
facility: NYU Langone Medical Center
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas HealthCare System Center for Liver Disease
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center - Duke South Clinics
state: North Carolina
city: Fayetteville
country: United States
facility: Cumberland Research Associates LLC
state: North Carolina
city: Huntersville
country: United States
facility: Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease
state: North Carolina
city: Rocky Mount
country: United States
facility: PMG Research of Rocky Mount, LLC
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Hershey
country: United States
facility: Penn State University, The Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute
state: Pennsylvania
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Charleston
country: United States
facility: Medical University of South Carolina, University Hospital
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System Gastroenterology and Liver Center
state: South Carolina
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Memphis
country: United States
facility: Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research PLLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - Digestive Disease Center
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Austin
country: United States
facility: Pinnacle Clinical Research, PLLC
state: Texas
city: Austin
country: United States
facility: Austin Center for Clinical Research
state: Texas
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Houston
country: United States
facility: Kelsey-Seybold Clinic
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Advanced Liver Therapies
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas, P.A.
state: Texas
city: Houston
country: United States
facility: Research Specialists of Texas
state: Texas
city: Houston
country: United States
facility: Smith Clinic
state: Texas
city: Live Oak
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Richardson
country: United States
facility: DHAT Research Institute
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation, The Texas Liver Institute
state: Texas
city: Murray
country: United States
facility: Intermountain Liver Disease and Transplant Clinic
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Burlington
country: United States
facility: The University of Vermont Medical Center
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Medical Campus
state: Virginia
city: Newport News
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia
state: Virginia
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason
state: Washington
city: Seattle
country: United States
facility: Swedish Organ Transplant and Liver Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
city: Kogarah
country: Australia
facility: St. George's Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane & Women's Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Fitzroy
country: Australia
facility: St. Vincent's Hospital Melbourne
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred Hospital, Alfred Health
state: Victoria
city: Nedlands
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
city: Perth
country: Australia
facility: Royal Perth Hospital
state: Western Australia
city: Graz
country: Austria
facility: Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus Wien
city: Brussels
country: Belgium
facility: UZ Brussel
city: Brussels
country: Belgium
facility: Cliniques Universitaires UCL Saint-Luc
city: Bruxelles
country: Belgium
facility: CUB Hopital Erasme
city: Ghent
country: Belgium
facility: Az Maria Middelares Ghent
city: Leuven
country: Belgium
facility: UZ Leuven
city: Calgary
country: Canada
facility: University of Calgary Liver Unit (Heritage Medical Research Clinic)
state: Alberta
city: Edmonton
country: Canada
facility: GI Research
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: LAIR Centre
state: British Columbia
city: Vancouver
country: Canada
facility: Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology
state: British Columbia
city: Victoria
country: Canada
facility: PerCuro Clinical Research Ltd.
state: British Columbia
city: Winnipeg
country: Canada
facility: University of Manitoba, Health Sciences Centre, John Buhler Research Centre
state: Manitoba
city: Bridgewater
country: Canada
facility: South Shore Medical Arts
state: Nova Scotia
city: Brampton
country: Canada
facility: William Osler Health System-Brampton Civic Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Center for Liver Diseases (TCLD), Toronto General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Liver Centre
state: Ontario
city: Montréal
country: Canada
facility: Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)
state: Quebec
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire Estaing
city: Créteil
country: France
facility: Hopital Henri Mondor
city: Grenoble
country: France
facility: CHU de Grenoble- Hopital Michallon
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire- Hopital Claude Huriez
city: Limoges
country: France
facility: CHU de Limoges- Hopital Dupuytren- Federation Hepatologie
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Marseille
country: France
facility: Hôpital Saint Joseph
city: Montpellier
country: France
facility: CHU de Montpellier, Hopital St Eloi
city: Nice
country: France
facility: Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2
city: Paris
country: France
facility: Hopital Cochin
city: Paris
country: France
facility: Groupe Hospitalier Universitaire La Pitie Salpetriere
city: Pessac
country: France
facility: Hopital Beaujon
city: Strasbourg
country: France
facility: Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil
city: Toulouse
country: France
facility: Centre Hospitalier Universitaire de Toulouse- Hopital Purpan
city: Aachen
country: Germany
facility: Uniklinik RWTH Aachen, Medizinische Klinik III
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn (AoR)
city: Frankfurt am main
country: Germany
facility: Universitatsklinikum Frankfurt der Goethe-Universitat
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig AoR
city: Mainz
country: Germany
facility: Johannes Gutenberg-Universitat
city: Sha Tin
country: Hong Kong
facility: Prince of Wales Hospital
city: Tai Po
country: Hong Kong
facility: Alice Ho Miu Ling Nethersole Hospital
city: Chandigarh
country: India
facility: Department of Hepatology PGIMER Chandigarh
city: Hyderabad
country: India
facility: Global Clinical Reseaech Services PVT LTD
city: Kolkata
country: India
facility: Institute of Post Graduate Medical Education and Research (IPGMER)
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
city: Mangalore
country: India
facility: Kasturba Medical College Hospital
city: Mumbai
country: India
facility: Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals
city: Nagpur
country: India
facility: Midas Multispecialty Hospital
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: New Delhi
country: India
facility: Fortis Flt. Lt. Rajan Dhall Hospital
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
city: Afula
country: Israel
facility: Emek Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Haifa
country: Israel
facility: The Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Petaẖ Tiqwa
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
city: Rozzano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Fukui
country: Japan
facility: Fukui-Ken Saiseikai Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hiroshima
country: Japan
facility: Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital
city: Izunokuni
country: Japan
facility: Juntendo University Shizuoka Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Kawasaki
country: Japan
facility: Toranomon Hospital Kajigaya
city: Kumamoto
country: Japan
facility: Kumamoto Shinto General Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kyoto
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Minato
country: Japan
facility: Toranomon Hospital
city: Miyazaki
country: Japan
facility: Miyazaki Medical Center Hospital
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
city: Nara
country: Japan
facility: Nara City Hospital
city: Okayama
country: Japan
facility: Kawasaki Medical School General Medical Center
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Hirakata Kohsai Hospital
city: Saga
country: Japan
facility: Saga University Hospital
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
city: Sapporo
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
city: Shinjuku
country: Japan
facility: Tokyo Womens Medical University Hospital
city: Suita
country: Japan
facility: Saiseikai Suita Hospital
city: Suita
country: Japan
facility: Osaka University Hospital
city: Tsu
country: Japan
facility: Mie University Hospital
city: Tōno
country: Japan
facility: Ehime University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Yokohama
country: Japan
facility: Yokohama City University Hospital
city: Ōmura
country: Japan
facility: National Hospital Organization Nagasaki Medical Center
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Goyang-si
country: Korea, Republic of
facility: National Health Insurance Service- Ilsan Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Mexico City
country: Mexico
facility: Consultorio Médico
city: Monterrey
country: Mexico
facility: Accelerium S. de R.L. de C.V.
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Dunedin
country: New Zealand
facility: Southern District Health Board - Dunedin Hospital
city: Bytom
country: Poland
facility: Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii
city: Mysłowice
country: Poland
facility: ID Clinic Arkadiusz Pisula
city: Łódź
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego
city: San Juan
country: Puerto Rico
facility: Klinical Investigations Group, LLC
city: San Juan
country: Puerto Rico
facility: VA Carribean Healthcare System
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
city: Singapore
country: Singapore
facility: National University Health System
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: Changi General Hospital Pte Ltd.
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital del Mar - Parc de Salut
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerto de Hierro Majadahonda
city: Pontevedra
country: Spain
facility: CHOP_Complejo Hospitalario Universitario de Pntevedra
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe de Valencia
city: Bern
country: Switzerland
facility: Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie
city: Lugano
country: Switzerland
facility: Istituto Cantanale di Patologia Locarno
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-LinKou Branch
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: King's College Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: St. George's Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
city: Swansea
country: United Kingdom
facility: Abertawe Bro Morgannwg University Health Board
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-Gomez M, Okanoue T, Trauner M, Kersey K, Li G, Han L, Jia C, Wang L, Chen G, Subramanian GM, Myers RP, Djedjos CS, Kohli A, Bzowej N, Younes Z, Sarin S, Shiffman ML, Harrison SA, Afdhal NH, Goodman Z, Younossi ZM. Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials. Hepatology. 2019 Nov;70(5):1521-1530. doi: 10.1002/hep.30842. Epub 2019 Aug 19.
citation: Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Romero-Gomez M, et al. Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [Poster SAT-273]. European Association for the Study of the Liver (EASL); 2019; Vienna Austria.
citation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, Romero-Gomez M, Kersey K, Li G, Subramanian GM, Myers RP, Djedjos CS, Okanoue T, Trauner M, Goodman Z, Harrison SA. Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2552-2560.e10. doi: 10.1016/j.cgh.2019.02.024. Epub 2019 Feb 16.
citation: Anstee QM, Lawitz EJ, Alkhouri N, Wai Sun Wong V, Romero-Gomez M, et al. Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [poster]. American Association for the Study of Liver Diseases (AASLD); 2018, San Francisco, CA.
citation: Younossi ZM, Lawitz E, Alkhouri N, Wong VWS, Romero-Gomez M, et al. Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data From the STELLAR clinical trials [Poster LB-10]. AASLD; 2018; San Francisco, CA.
citation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, et al. Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to non-alcoholic steatohepatitis (NASH) [Poster]. AASLD; 2018; San Francisco, CA.
citation: Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai Sun Wong V, et al. Advanced fibrosis based on noninvasive tests in nonalcoholic steatohepatitis (NASH) is associated with impairment of patient-reported outcomes [Poster]. AASLD; 2018; San Francisco, CA.
citation: Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3; STELLAR-4 Investigators. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6.
citation: Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8.
citation: Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2093-2100.e3. doi: 10.1016/j.cgh.2019.01.001. Epub 2019 Jan 11.