Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

Nonalcoholic Steatohepatitis Clinical Trial

— STELLAR-3  

Official title:

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03053050
• Other study ID #: GS-US-384-1943
• Secondary ID: 2016-004374-18
• Status: Terminated
• Phase: Phase 3
• Start date: February 13, 2017
• Est. completion date: June 19, 2019

Study information

• Verified date: June 2020
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in adults with NASH and bridging (F3) fibrosis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 808
• Est. completion date: June 19, 2019
• Est. primary completion date: June 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Key Inclusion Criteria:

• Liver biopsy consistent with NASH and bridging (F3 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:

• 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

• Hemoglobin A1c (HbA1c) = 9.5% (or serum fructosamine = 381 µmol if HbA1c is unable to be resulted)

• Total bilirubin = 1.3 x ULN (unless an alternate etiology such as Gilbert's syndrome or hemolytic anemia is present)

Key Exclusion Criteria:

• Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding

• Child-Pugh (CP) score > 6, 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-antitryspin 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.

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Intervention

Drug:
• SEL
Tablets administered orally once daily
• Placebo to match SEL 6 mg
Tablets administered orally once daily
• Placebo to match SEL 18 mg
Tablets administered orally once daily

Locations

Country	Name	City	State
Argentina	Hospital Italiano de Buenos Aires	Buenos Aires
Argentina	Instituto Oulton	Córdoba
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Monash Health, Monash Medical Centre	Clayton	Victoria
Australia	St. Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	St. Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Austin Hospital	Heidelberg	Victoria
Australia	Royal Brisbane & Women's Hospital	Herston	Queensland
Australia	St. George's Hospital	Kogarah	New South Wales
Australia	The Alfred Hospital, Alfred Health	Melbourne	Victoria
Australia	Royal Perth Hospital	Perth	Western Australia
Australia	Westmead Hospital	Westmead	New South Wales
Austria	Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin	Graz
Austria	Allgemeines Krankenhaus Wien	Vienna
Belgium	UZ Brussel	Brussel
Belgium	CUB Hopital Erasme	Brussels
Belgium	Universitaire Ziekenhuizen Leuven	Leuven
Brazil	Hospital das Clínicas da Faculdade de Medicina de Botucatu - FMB/Universidade Estadual Paulista Julio de Mesquita Filho - UNESP	Botucatu
Brazil	Hospital de Clínicas de Porto Alegre - HCPA/UFRGS	Porto Alegre
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP	Ribeirão Preto
Brazil	Hospital Das Clinicas Da Faculdade De Medicina Da Universidade De Sao Paulo	São Paulo
Brazil	Universidade Federal de São Paulo / Unidade Ambulatorial de Pesquisa Clínica - I (UAPC-I)	São Paulo
Canada	William Osler Health System-Brampton Civic Hospital	Brampton	Ontario
Canada	South Shore Medical Arts	Bridgewater	Nova Scotia
Canada	University of Calgary Liver Unit (Heritage Medical Research Clinic)	Calgary	Alberta
Canada	University of Alberta Hospital - Walter C. Mackenzie Health Sciences Centre (WMC)	Edmonton	Alberta
Canada	South Shore Medical Arts	London	Ontario
Canada	Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC)	Montréal	Quebec
Canada	Toronto Center for Liver Diseases (TCLD), Toronto General Hospital	Toronto	Ontario
Canada	(G.I.R.I.) GI Research Institute	Vancouver	British Columbia
Canada	Gordon and Leslie Diamond Health Care Centre	Vancouver	British Columbia
Canada	LAIR Centre	Vancouver	British Columbia
Canada	PerCuro Clinical Research Ltd.	Victoria	British Columbia
France	Centre Hospitalier Universitaire d'Angers	Angers
France	Centre Hospitalier Universitaire Estaing	Clermont-Ferrand
France	Hopital Henri Mondor	Créteil
France	CHU de Grenoble- Hopital Michallon	Grenoble
France	Centre Hospitalier Regional Universitaire- Hopital Claude Huriez	Lille
France	CHU de Limoges- Hopital Dupuytren- Federation Hepatologie	Limoges
France	Hopital de la Croix Rousse	Lyon
France	Hôpital Saint Joseph	Marseille
France	Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2	Nice
France	Hopital Cochin	Paris
France	Centre Hospitalier Universitaire de Bordeaux	Pessac
France	Hopital Beaujon	Pessac
France	Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil	Strasbourg
France	Centre Hospitalier Universitaire de Toulouse- Hopital Purpan	Toulouse
France	Hopital Paul Brousse	Villejuif
Germany	Uniklinik RWTH Aachen, Medizinische Klinik III	Aachen
Germany	Zentrum fur Infektiologie Berlin Prenzlauer Berg GmbH (zibp)	Berlin
Germany	Universitatsklinikum Bonn (AoR)	Bonn
Germany	Universitatsklinikum Frankfurt der Goethe-Universitat	Frankfurt
Germany	Medizinische Hochschule Hannover	Hanover
Germany	Uniklinikum des Saarlandes- Klinik fur Innere Medizin II	Homburg
Germany	Gastroenterologisch- Hepatologisches Zentrum Kiel	Kiel
Germany	Eugastro Gmbh	Leipzig
Germany	Johannes Gutenberg-Universitat	Mainz
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Tai Po
Hong Kong	Tuen Mun Hospital	Tuen Mun
India	Institute of Post Graduate Medical Education and Research / SSKM Hospital	Kolkata
India	Kasturba Medical College (KMC) Hospital	Mangalore
India	Global Hospital-Super Speciality & Transplant Centre (A Unit of Centre for Digestive and Kidney Diseases (India) Pvt. Ltd.)	Mumbai
India	Midas Multispecialty Hospital	Nagpur	Maharashtra
India	All India Institute of Medical Sciences	New Delhi
India	Fortis Flt. Lt. Rajan Dhall Hospital	New Delhi
India	Institute of Liver & Biliary Sciences	New Delhi
India	Maharaja Agrasen Hospital	New Delhi
Israel	Rambam Health Care Campus	Haifa
Israel	The Lady Davis Carmel Medical Center	Haifa
Israel	Holy Family hospital	Nazaret
Israel	The Chaim Sheba Medical Center	Ramat Gan
Israel	Tel-Aviv Sourasky Medical Center	Tel Aviv
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	IRCCS Ospedale Casa Sollievo Della Soferrenza	San Giovanni Rotondo
Japan	Chiba University Hospital	Chiba
Japan	Fukui-Ken Saiseikai Hospital	Fukui-shi
Japan	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital	Hiroshima
Japan	Hiroshima University Hospital	Hiroshima
Japan	Tokyo Medical University Ibaraki Medical Center	Ibaraki
Japan	Juntendo University Shizuoka Hospital	Izunokuni
Japan	Kagoshima University Medical And Dental Hospital	Kagoshima
Japan	Kanazawa University Hospital	Kanagawa
Japan	Nara Medical University Hospital	Kashihara
Japan	Toranomon Hospital Kajigaya	Kawasaki
Japan	Shinkokura Hospital	Kitakyushu
Japan	Kumamoto Shinto General Hospital	Kumamoto
Japan	Kurume University Hospital	Kurume
Japan	University Hospital, Kyoto Prefectural University of Medicine	Kyoto
Japan	Shinshu University Hospital	Matsumoto
Japan	Toranomon Hospital	Minato
Japan	Miyazaki Medical Center Hospital	Miyazaki
Japan	Japanese Red Cross Musashino Hospital	Musashino
Japan	Aichi Medical University Hospital	Nagakute
Japan	Heart Life Hospital	Nakagami
Japan	Nara City Hospital	Nara
Japan	Hyogo College of Medicine Hospital	Nishinomiya
Japan	Kawasaki Medical School General Medical Center	Okayama
Japan	Okayama University Hospital	Okayama
Japan	National Hospital Organization Nagasaki Medical Center	Omura
Japan	Hirakata Kohsai Hospital	Osaka
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Saga University Hospital	Saga
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital	Sapporo
Japan	Tohoku Rosai Hospital	Sendai
Japan	National Center for Global Health and Medicine Hospital	Shinjuku-ku
Japan	Saiseikai Suita Hospital	Suita
Japan	Kagawa Prefectural Central Hospital	Takamatsu
Japan	Ehime University Hospital	Tono
Japan	Mie University Hospital	Tsu
Japan	Yamagata University Hospital	Yamagata
Japan	Yokohama City University Hospital	Yokohama
Korea, Republic of	Keimyung University Dongsan Medical Center	Daegu
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	National Health Insurance Service- Ilsan Hospital	Goyang-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Chung-Ang University Hospital	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju
Malaysia	Hospital Selayang	Batu Caves
Malaysia	University of Malaya Medical Centre	Kuala Lumpur
Mexico	Phylasis Clinicas Research S. de RL de CV.	Cuautitlán
Mexico	Consultorio Médico	Mexico City
Mexico	Investigaciones Medicas Cisneros SC	Monterrey
Netherlands	University Medical Center Utrecht	Utrecht
New Zealand	Auckland City Hospital	Grafton
Poland	Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii	Bytom
Poland	Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego	Lódz
Portugal	Centro Hospitalar de Tras-os-Montes e Alto Douro, E.P.E	Vila Real
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
Puerto Rico	Klinical Investigations Group, LLC	San Juan
Puerto Rico	VA Caribbean Healthcare System	San Juan
Singapore	Changi General Hospital Pte Ltd.	Singapore
Singapore	Khoo Teck Puat Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Singapore	Tan Tock Seng Hospital	Singapore
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Puerto de Hierro Majadahonda	Majadahonda
Spain	CHOP_Complejo Hospitalrio Universitario de Pontevedra	Pontevedra
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Switzerland	Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie	Bern
Switzerland	Istituto Cantonale di Patologia Locarno	Lugano
Taiwan	Changhua Christian Hospital	Chang-hua
Taiwan	Ditmanson Medical Foundation Chia-Yi Christian Hospital	Chiayi City
Taiwan	E-DA Hospital	Kaohsiung
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	Chang Gung Medical Foundation, Keelung Chang Gung Memorial Hospital	Keelung
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	National Cheng Kung University Hospitalv	Tainan
Taiwan	Cathay General Hospital	Taipei
Taiwan	Mackay Memorial Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital	Taoyuan
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge
United Kingdom	Derby Teaching Hospitals NHS FT	Derby
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Edgbaston
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	The Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle upon Tyne
United Kingdom	Norfolk and Norwich University Hospitals NHS Foundation Trust	Norwich
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth
United Kingdom	Abertawe Bro Morgannwg University Health Board	Swansea
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	Digestive Healthcare of Georgia	Atlanta	Georgia
United States	Piedmont Transplant Institute	Atlanta	Georgia
United States	University of Colorado	Aurora	Colorado
United States	Austin Center for Clinical Research	Austin	Texas
United States	Pinnacle Clinical Research, PLLC	Austin	Texas
United States	Mercy Medical Center	Baltimore	Maryland
United States	Delta Research Partners, LLC	Bastrop	Louisiana
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Northeast Clinical Research Center, LLC	Bethlehem	Pennsylvania
United States	University of Buffalo, Clinical and Translational Research Center	Buffalo	New York
United States	The University of Vermont Medical Center	Burlington	Vermont
United States	Digestive Disease Associates, PA	Catonsville	Maryland
United States	Institute of Liver Health	Chandler	Arizona
United States	University of North Carolina at Chapel Hill / UNC School of Medicine	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Virginia Medical Center	Charlottesville	Virginia
United States	WR-ClinSearch, LLC	Chattanooga	Tennessee
United States	Northwestern Memorial Hospital; Clinical Research Unit	Chicago	Illinois
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	eStudySite	Chula Vista	California
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	UC Health/Holmes Hospital	Cincinnati	Ohio
United States	Southern California Liver Centers	Coronado	California
United States	United Gastroenterologists	Costa Mesa	California
United States	Texas Digestive Disease Consultants	Dallas	Texas
United States	The Liver Institute at Methodist Dallas Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Integrity Clinical Research, LLC	Doral	Florida
United States	Duke University Medical Center - Duke South Clinics	Durham	North Carolina
United States	TriWest Research Associates, LLC	El Cajon	California
United States	Verity Research, Inc.	Fairfax	Virginia
United States	Inova Fairfax Medical Campus	Falls Church	Virginia
United States	Cumberland Research Associates, LLC	Fayetteville	North Carolina
United States	Baylor Scott & White All Saints Medical Center	Fort Worth	Texas
United States	Fresno Clinical Research Center	Fresno	California
United States	UF Hepatology Research at CTRB	Gainesville	Florida
United States	Gastro One	Germantown	Tennessee
United States	NorthShore University Healthsystem	Glenview	Illinois
United States	Triad Clinical Trials LLC	Greensboro	North Carolina
United States	Greenville Health System - Gastroenterology and Liver Center	Greenville	South Carolina
United States	Meritus Center for Clinical Research	Hagerstown	Maryland
United States	Gastroenterology Associates of Hazard	Hazard	Kentucky
United States	Baylor College of Medicine - Advanced Liver Therapies	Houston	Texas
United States	Kelsey-Seybold Clinic	Houston	Texas
United States	VAMC & Baylor College	Houston	Texas
United States	Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease	Huntersville	North Carolina
United States	Indiana University Health - University Hospital	Indianapolis	Indiana
United States	Indianapolis Gastroenterology Research Foundation	Indianapolis	Indiana
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	UF Health Jacksonville-Gastroenterology Emerson	Jacksonville	Florida
United States	Kansas City Gastroenterology and Hepatology	Kansas City	Missouri
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California San Diego (UCSD)	La Jolla	California
United States	Florida Research Institute	Lakewood Ranch	Florida
United States	Emeritas Research Group	Lansdowne Town Center	Virginia
United States	eStudySite	Las Vegas	Nevada
United States	Sunrise Medical Research, Inc	Lauderdale Lakes	Florida
United States	Baptist Medical Center	Little Rock	Arkansas
United States	Pinnacle Clinical Research, PLLC	Live Oak	Texas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Ruane Clinical Research Group	Los Angeles	California
United States	VA Greater Los Angeles Healthcare System	Los Angeles	California
United States	Northwell Health - Sandra Atlas Bass Center for Liver Diseases	Manhasset	New York
United States	Gastrointestinal Specialists of Georgia, PC	Marietta	Georgia
United States	Genoma Research Group, Inc	Miami	Florida
United States	Schiff Center for Liver Diseases/University of Miami	Miami	Florida
United States	Sunrise Research Institute	Miami	Florida
United States	Froedtert Memorial Lutheran Hospital	Milwaukee	Wisconsin
United States	University of Minnesota Medical Center - Fairview	Minneapolis	Minnesota
United States	Intermountain Liver Disease and Transplant Center	Murray	Utah
United States	Quality Medical Research PLLC	Nashville	Tennessee
United States	Vanderbilt University Medical Center - Digestive Disease Center	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Ocshner Medical Center	New Orleans	Louisiana
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Advanced Research Institute	New Port Richey	Florida
United States	Icahn School of Medicine at Mount Sinai Beth Israel	New York	New York
United States	Rutgers New Jersey Medical School- Doctors Office Center	Newark	New Jersey
United States	Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia	Newport News	Virginia
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	eStudySite	Oceanside	California
United States	Avail Clinical Research, LLC	Orange City	Florida
United States	California Liver Institute	Pasadena	California
United States	Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Banner University Medical Center-Phoenix	Phoenix	Arizona
United States	Mayo Clinic	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	eStudySite	Pittsburgh	Pennsylvania
United States	UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute	Pittsburgh	Pennsylvania
United States	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania
United States	University Gastroenterology	Providence	Rhode Island
United States	Inland Empire Liver Foundation	Rialto	California
United States	Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia	Richmond	Virginia
United States	McGuire VA Medical Center	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Southern Therapy and Advanced Research LLC (STAR)	Ridgeland	Mississippi
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	PMG Research of Rocky Mount, LLC	Rocky Mount	North Carolina
United States	University of California, Davis Medical Center	Sacramento	California
United States	Saint Louis University	Saint Louis	Missouri
United States	University of Utah Hospital	Salt Lake City	Utah
United States	American Research Corporation, The Texas Liver Institute	San Antonio	Texas
United States	Kaiser Permanente	San Diego	California
United States	Medical Associates Research Group	San Diego	California
United States	California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant	San Francisco	California
United States	Mission Gastroenterology and Hepatology	San Francisco	California
United States	University of California San Francisco (UCSF)	San Francisco	California
United States	Silicon Valley Research Institute	San Jose	California
United States	Guthrie Medical Group, PC	Sayre	Pennsylvania
United States	Swedish Organ Transplant and Liver Center	Seattle	Washington
United States	Virginia Mason	Seattle	Washington
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease	Statesville	North Carolina
United States	University of Arizona	Tucson	Arizona
United States	South Florida Center of Gastroenterology, PA	Wellington	Florida
United States	Digestive Health Specialists, PA	Winston-Salem	North Carolina
United States	Gastroenterology Associates of Western Michigan, P.L.C.	Wyoming	Michigan
United States	Huron Gastroenterology Associates/Center for Digestive Care	Ypsilanti	Michigan
United States	Florida Medical Clinic, PA	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  France,  Germany,  Hong Kong,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Poland,  Portugal,  Puerto Rico,  Singapore,  Spain,  Switzerland,  Taiwan,  United Kingdom, 

References & Publications (7)

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

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 th

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, Youn — View 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, C

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.

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.

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Who Achieved a = 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48	Fibrosis improvement was defined as = 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as = 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.	Week 48
Primary	Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event	EFS was assessed by the time to the first clinical event, including progression to cirrhosis on liver biopsy, liver decompensation events, liver transplantation, and all-cause mortality.	Week 240
Secondary	Percentage of Participants Who Had Progression to Cirrhosis at Week 48	Progression to cirrhosis was defined as a change in NASH CRN fibrosis stage from < 4 at baseline to 4 at Week 48.	Week 48
Secondary	Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240	Fibrosis improvement was defined as = 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as = 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the NAS criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.	Week 240
Secondary	Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis at Week 48	Fibrosis improvement was defined as = 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).	Week 48
Secondary	Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis at Week 240	Fibrosis improvement was defined as = 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).	Week 240
Secondary	Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48	NASH resolution was defined as lobular inflammation of 0 or 1 from = 1 at baseline and hepatocellular ballooning of 1 from a value = 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning = 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.	Week 48
Secondary	Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240	NASH resolution was defined as lobular inflammation of 0 or 1 from = 1 at baseline and hepatocellular ballooning of 1 from a value = 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning = 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.	Week 240