Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)

Nonalcoholic Steatohepatitis Clinical Trial

— STELLAR-4  

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03053063
• Other study ID #: GS-US-384-1944
• Secondary ID: 2016-004148-13
• Status: Terminated
• Phase: Phase 3
• Start date: January 30, 2017
• Est. completion date: May 6, 2019

Study information

• Verified date: April 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 associated complications in adults with cirrhosis due to NASH.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 883
• Est. completion date: May 6, 2019
• Est. primary completion date: May 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

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
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Monash Medical Centre	Clayton	Victoria
Australia	St. Vincent's Hospital Sydney	Darlinghurst	New South Wales
Australia	Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	St. Vincent's Hospital Melbourne	Fitzroy	Victoria
Australia	Austin Health	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	Sir Charles Gairdner Hospital	Nedlands	Western Australia
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	Cliniques Universitaires UCL Saint-Luc	Brussels
Belgium	UZ Brussel	Brussels
Belgium	CUB Hopital Erasme	Bruxelles
Belgium	Az Maria Middelares Ghent	Ghent
Belgium	UZ Leuven	Leuven
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	GI Research	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	McMaster University Medical Centre	Hamilton	Ontario
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	London Health Sciences Centre - University Hospital	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	Toronto Liver Centre	Toronto	Ontario
Canada	Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology	Vancouver	British Columbia
Canada	LAIR Centre	Vancouver	British Columbia
Canada	PerCuro Clinical Research Ltd.	Victoria	British Columbia
Canada	University of Manitoba, Health Sciences Centre, John Buhler Research Centre	Winnipeg	Manitoba
France	CHU Amiens Picardie	Amiens
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	CHU de Montpellier, Hopital St Eloi	Montpellier
France	Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2	Nice
France	Groupe Hospitalier Universitaire La Pitie Salpetriere	Paris
France	Hopital Cochin	Paris
France	Hopital Beaujon	Pessac
France	Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil	Strasbourg
France	Centre Hospitalier Universitaire de Toulouse- Hopital Purpan	Toulouse
Germany	Uniklinik RWTH Aachen, Medizinische Klinik III	Aachen
Germany	Universitatsklinikum Bonn (AoR)	Bonn
Germany	Universitatsklinikum Frankfurt der Goethe-Universitat	Frankfurt am main
Germany	Universitatsklinikum Leipzig AoR	Leipzig
Germany	Johannes Gutenberg-Universitat	Mainz
Hong Kong	Prince of Wales Hospital	Sha Tin
Hong Kong	Alice Ho Miu Ling Nethersole Hospital	Tai Po
India	Department of Hepatology PGIMER Chandigarh	Chandigarh
India	Global Clinical Reseaech Services PVT LTD	Hyderabad
India	Institute of Post Graduate Medical Education and Research (IPGMER)	Kolkata
India	Dayanand Medical College & Hospital	Ludhiana
India	Kasturba Medical College Hospital	Mangalore
India	Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals	Mumbai
India	Midas Multispecialty Hospital	Nagpur
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
Israel	Emek Medical Center	Afula
Israel	Rambam Health Care Campus	Haifa
Israel	The Lady Davis Carmel Medical Center	Haifa
Israel	Shaare Zedek Medical Center	Jerusalem
Israel	Rabin Medical Center	Peta? Tiqwa
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	IRCCS Istituto Clinico Humanitas	Rozzano
Japan	Fukui-Ken Saiseikai Hospital	Fukui
Japan	Kyushu University Hospital	Fukuoka
Japan	Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital	Hiroshima
Japan	Juntendo University Shizuoka Hospital	Izunokuni
Japan	Kanazawa University Hospital	Kanazawa
Japan	Nara Medical University Hospital	Kashihara
Japan	Toranomon Hospital Kajigaya	Kawasaki
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	Aichi Medical University Hospital	Nagakute
Japan	Nara City Hospital	Nara
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	Saga University Hospital	Saga
Japan	Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital	Sapporo
Japan	Hokkaido University Hospital	Sapporo
Japan	Tokyo Womens Medical University Hospital	Shinjuku
Japan	Osaka University Hospital	Suita
Japan	Saiseikai Suita Hospital	Suita
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	Inha University Hospital	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Gangnam Severance Hospital	Seoul
Korea, Republic of	Korea University Guro Hospital	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Mexico	Consultorio Médico	Mexico City
Mexico	Accelerium S. de R.L. de C.V.	Monterrey
New Zealand	Auckland City Hospital	Auckland
New Zealand	Southern District Health Board - Dunedin Hospital	Dunedin
Poland	Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii	Bytom
Poland	Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego	Lódz
Poland	ID Clinic Arkadiusz Pisula	Myslowice
Puerto Rico	Fundacion de Investigacion de Diego	San Juan
Puerto Rico	Klinical Investigations Group, LLC	San Juan
Puerto Rico	VA Carribean Healthcare System	San Juan
Singapore	Changi General Hospital Pte Ltd.	Singapore
Singapore	National University Health System	Singapore
Singapore	Singapore General Hospital	Singapore
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcón
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital del Mar - Parc de Salut	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario La Paz	Madrid
Spain	Hospital Universitario Puerto de Hierro Majadahonda	Majadahonda
Spain	CHOP_Complejo Hospitalario Universitario de Pntevedra	Pontevedra
Spain	Hospital Universitario Marques de Valdecilla	Santander
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Consorcio Hospital General Universitario de Valencia	Valencia
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Switzerland	Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie	Bern
Switzerland	Istituto Cantanale di Patologia Locarno	Lugano
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Medical Foundation-LinKou Branch	Taoyuan
United Kingdom	NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	King's College Hospital NHS Foundation Trust	London
United Kingdom	St. George's Hospital	London
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Plymouth Hospitals NHS Trust	Plymouth
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth
United Kingdom	Abertawe Bro Morgannwg University Health Board	Swansea
United States	AccumetRx Clinical Research	Albuquerque	New Mexico
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 Denver and Hospital	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	Bastrop	Louisiana
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
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	NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Medical University of South Carolina, University Hospital	Charleston	South Carolina
United States	Carolinas HealthCare System Center for Liver Disease	Charlotte	North 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	Rush University Medical Center	Chicago	Illinois
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	University of Cincinnati	Cincinnati	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Iowa Digestive Disease Center, P.C.	Clive	Iowa
United States	Columbus Regional Research Institute	Columbus	Georgia
United States	Southern California Research Center	Coronado	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	South Denver Gastroenterology, PC	Englewood	Colorado
United States	Inova Fairfax Medical Campus	Falls Church	Virginia
United States	Cumberland Research Associates LLC	Fayetteville	North Carolina
United States	Fresno Clinical Research Center	Fresno	California
United States	University of Florida Hepatology Research at CTRB	Gainesville	Florida
United States	Gastro One	Germantown	Tennessee
United States	NorthShore University HealthSystem - Glenbrook ACC	Glenview	Illinois
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	Penn State University, The Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Clinical Research of Homestead	Homestead	Florida
United States	Baylor College of Medicine - Advanced Liver Therapies	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	Kelsey-Seybold Clinic	Houston	Texas
United States	Liver Associates of Texas, P.A.	Houston	Texas
United States	Research Specialists of Texas	Houston	Texas
United States	Smith Clinic	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	Nature Coast Clinical Research	Inverness	Florida
United States	Kansas City Research Institute	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	Scripps Clinical Research Services	La Jolla	California
United States	University of California, San Diego (Altman Clinical and Translational Research Center)	La Jolla	California
United States	Florida Research Institute	Lakewood Ranch	Florida
United States	Baptist Medical Center	Little Rock	Arkansas
United States	Pinnacle Clinical Research	Live Oak	Texas
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Ruane Clinical Research Group	Los Angeles	California
United States	Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center	Los Angeles	California
United States	University of Louisville Clinical Trials Unit	Louisville	Kentucky
United States	Gastroenterology Associates of Central Georgia, LLC	Macon	Georgia
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	Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research	Memphis	Tennessee
United States	Schiff Center for Liver Diseases/University of Miami	Miami	Florida
United States	Intermountain Liver Disease and Transplant Clinic	Murray	Utah
United States	Quality Medical Research PLLC	Nashville	Tennessee
United States	Vanderbilt University Medical Center - Digestive Disease Center	Nashville	Tennessee
United States	Ocshner Medical Center	New Orleans	Louisiana
United States	Tulane University Health Sciences Center	New Orleans	Louisiana
United States	Icahn School of Medicine at Mount Sinai	New York	New York
United States	Icahn School of Medicine at Mount Sinai Beth Israel	New York	New York
United States	NYU Langone Medical Center	New York	New York
United States	Weill Cornell Medical College	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	Florida Hospital Transplant Institute	Orlando	Florida
United States	IMIC Inc	Palmetto	Florida
United States	California Liver Research Institute	Pasadena	California
United States	Huntington Medical Research Institutes (HMRI) Liver Center	Pasadena	California
United States	Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Mayo Clinic	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute	Pittsburgh	Pennsylvania
United States	University Gastroenterology	Providence	Rhode Island
United States	Inland Empire Liver Foundation	Rialto	California
United States	DHAT Research Institute	Richardson	Texas
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	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	Research and Education, Inc.	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	eStudySite	San Francisco	California
United States	University of California, San Francisco-Liver Clinic	San Francisco	California
United States	Swedish Organ Transplant and Liver Center	Seattle	Washington
United States	University of Washington	Seattle	Washington
United States	Virginia Mason	Seattle	Washington
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Piedmont Healthcare	Statesville	North Carolina
United States	Island View Gastroenterology Associates- Ventura	Ventura	California
United States	South Florida Center of Gastroenterology, PA	Wellington	Florida
United States	Cleveland Clinic Florida	Weston	Florida
United States	Digestive Health Specialists, PA	Winston-Salem	North Carolina
United States	University of Massachusetts Medical School	Worcester	Massachusetts
United States	Gastroenterology Associates of Western Michigan, P.L.C.	Wyoming	Michigan
United States	Florida Medical Clinic, PA	Zephyrhills	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

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

References & Publications (8)

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

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 — 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 Achieve a = 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH	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 liver decompensation events, liver transplantation and all-cause mortality.	Week 240
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 at Week 48	NASH resolution was defined as lobular inflammation of 0 or 1 from = 1 at baseline and hepatocellular ballooning reduced to 0 from a value = 1 at baseline; both criteria were necessary conditions. 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. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning = 1.	Week 48
Secondary	Percentage of Participants Who Had NASH Resolution at Week 240	NASH resolution was defined as lobular inflammation of 0 or 1 from = 1 at baseline and hepatocellular ballooning reduced to 0 from a value = 1 at baseline; both criteria were necessary conditions.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. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning = 1.	Week 240