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)

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

Sponsors

Lead sponsor: Gilead Sciences

Source Gilead Sciences
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.

Overall Status Terminated
Start Date January 30, 2017
Completion Date May 6, 2019
Primary Completion Date May 6, 2019
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
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 Week 48
Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event Week 240
Secondary Outcome
Measure Time Frame
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240 Week 240
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48 Week 48
Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240 Week 240
Percentage of Participants Who Had NASH Resolution at Week 48 Week 48
Percentage of Participants Who Had NASH Resolution at Week 240 Week 240
Enrollment 883
Condition
Intervention

Intervention type: Drug

Intervention name: SEL

Description: Tablets administered orally once daily

Intervention type: Drug

Intervention name: Placebo to match SEL 6 mg

Description: Tablets administered orally once daily

Intervention type: Drug

Intervention name: Placebo to match SEL 18 mg

Description: Tablets administered orally once daily

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.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Gilead Study Director Study Director Gilead Sciences
Location
facility
Institute of Liver Health | Chandler, Arizona, 85224, United States
St. Joseph's Hospital and Medical Center | Phoenix, Arizona, 85013, United States
Mayo Clinic | Phoenix, Arizona, 85054, United States
Baptist Medical Center | Little Rock, Arkansas, 72204, United States
Arkansas Gastroenterology | North Little Rock, Arkansas, 72117, United States
Southern California Research Center | Coronado, California, 92118, United States
Fresno Clinical Research Center | Fresno, California, 93720, United States
Scripps Clinical Research Services | La Jolla, California, 92037, United States
University of California, San Diego (Altman Clinical and Translational Research Center) | La Jolla, California, 92093, United States
Ruane Clinical Research Group | Los Angeles, California, 90036, United States
Cedars-Sinai Medical Center | Los Angeles, California, 90048, United States
Veterans Affair Greater Los Angeles Healthcare System, West Los Angeles VA Medical Center | Los Angeles, California, 90073, United States
California Liver Research Institute | Pasadena, California, 91105, United States
Huntington Medical Research Institutes (HMRI) Liver Center | Pasadena, California, 91105, United States
Inland Empire Liver Foundation | Rialto, California, 92377, United States
University of California, Davis Medical Center | Sacramento, California, 95817, United States
Research and Education, Inc. | San Diego, California, 92105, United States
Medical Associates Research Group | San Diego, California, 92123, United States
Kaiser Permanente | San Diego, California, 92514, United States
California Pacific Medical Center - Sutter Pacific Medical Foundation San Francisco Center for Liver Disease Dept. of Transplant | San Francisco, California, 94115, United States
eStudySite | San Francisco, California, 94115, United States
University of California, San Francisco-Liver Clinic | San Francisco, California, 94143, United States
Island View Gastroenterology Associates- Ventura | Ventura, California, 93003, United States
University of Colorado Denver and Hospital | Aurora, Colorado, 80045, United States
South Denver Gastroenterology, PC | Englewood, Colorado, 80113, United States
Integrity Clinical Research, LLC | Doral, Florida, 33166, United States
University of Florida Hepatology Research at CTRB | Gainesville, Florida, 32610, United States
Clinical Research of Homestead | Homestead, Florida, 33030, United States
Nature Coast Clinical Research | Inverness, Florida, 34452, United States
Florida Research Institute | Lakewood Ranch, Florida, 34211, United States
Schiff Center for Liver Diseases/University of Miami | Miami, Florida, 33136, United States
Florida Hospital Transplant Institute | Orlando, Florida, 32804, United States
IMIC Inc | Palmetto, Florida, 33157, United States
South Florida Center of Gastroenterology, PA | Wellington, Florida, 33414, United States
Cleveland Clinic Florida | Weston, Florida, 33331, United States
Florida Medical Clinic, PA | Zephyrhills, Florida, 33540, United States
Digestive Healthcare of Georgia | Atlanta, Georgia, 30309, United States
Piedmont Transplant Institute | Atlanta, Georgia, 30309, United States
Columbus Regional Research Institute | Columbus, Georgia, 31904, United States
Gastroenterology Associates of Central Georgia, LLC | Macon, Georgia, 31201, United States
Gastrointestinal Specialists of Georgia, PC | Marietta, Georgia, 30060, United States
Northwestern Memorial Hospital; Clinical Research Unit | Chicago, Illinois, 60611, United States
Rush University Medical Center | Chicago, Illinois, 60612, United States
The University of Chicago Medical Center | Chicago, Illinois, 60615, United States
NorthShore University HealthSystem - Glenbrook ACC | Glenview, Illinois, 60026, United States
Indiana University Health - University Hospital | Indianapolis, Indiana, 46202, United States
Indianapolis Gastroenterology Research Foundation | Indianapolis, Indiana, 46237, United States
Iowa Digestive Disease Center, P.C. | Clive, Iowa, 50325, United States
University of Kansas Medical Center | Kansas City, Kansas, 66160, United States
Gastroenterology Associates of Hazard | Hazard, Kentucky, 41707, United States
University of Louisville Clinical Trials Unit | Louisville, Kentucky, 40202, United States
Delta Research Partners | Bastrop, Louisiana, 71021, United States
Tulane University Health Sciences Center | New Orleans, Louisiana, 70112, United States
Ocshner Medical Center | New Orleans, Louisiana, 70121, United States
Louisiana Research Center, LLC | Shreveport, Louisiana, 71105, United States
Mercy Medical Center | Baltimore, Maryland, 21202, United States
Walter Reed National Military Medical Center | Bethesda, Maryland, 20889, United States
Digestive Disease Associates, PA | Catonsville, Maryland, 21228, United States
Meritus Center for Clinical Research | Hagerstown, Maryland, 21742, United States
Massachusetts General Hospital | Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center | Boston, Massachusetts, 02215, United States
University of Massachusetts Medical School | Worcester, Massachusetts, 01655, United States
Henry Ford Health System | Detroit, Michigan, 48202, United States
Gastroenterology Associates of Western Michigan, P.L.C. | Wyoming, Michigan, 49519, United States
Mayo Clinic | Rochester, Minnesota, 55905, United States
Southern Therapy and Advanced Research LLC (STAR) | Ridgeland, Mississippi, 39157, United States
Saint Luke's Hospital of Kansas City | Kansas City, Missouri, 64111, United States
Kansas City Research Institute | Kansas City, Missouri, 64131, United States
Saint Louis University | Saint Louis, Missouri, 63104, United States
Rutgers New Jersey Medical School- Doctors Office Center | Newark, New Jersey, 07102, United States
AccumetRx Clinical Research | Albuquerque, New Mexico, 87109, United States
Montefiore Medical Center | Bronx, New York, 10467, United States
University of Buffalo, Clinical and Translational Research Center | Buffalo, New York, 14230, United States
Northwell Health - Sandra Atlas Bass Center for Liver Diseases | Manhasset, New York, 11030, United States
Icahn School of Medicine at Mount Sinai Beth Israel | New York, New York, 10003, United States
NYU Langone Medical Center | New York, New York, 10016, United States
Weill Cornell Medical College | New York, New York, 10021, United States
Icahn School of Medicine at Mount Sinai | New York, New York, 10029, United States
University of Rochester Medical Center | Rochester, New York, 14642, United States
NC TraCS Institute- CTRC, University of North Carolina at Chapel Hill | Chapel Hill, North Carolina, 27599, United States
Carolinas HealthCare System Center for Liver Disease | Charlotte, North Carolina, 28204, United States
Duke University Medical Center - Duke South Clinics | Durham, North Carolina, 27710, United States
Cumberland Research Associates LLC | Fayetteville, North Carolina, 28304, United States
Piedmont HealthCare, d/b/a Carolinas Center for Liver Disease | Huntersville, North Carolina, 28078, United States
PMG Research of Rocky Mount, LLC | Rocky Mount, North Carolina, 27804, United States
Piedmont Healthcare | Statesville, North Carolina, 28677, United States
Digestive Health Specialists, PA | Winston-Salem, North Carolina, 27103, United States
Consultants for Clinical Research | Cincinnati, Ohio, 45249, United States
University of Cincinnati | Cincinnati, Ohio, 45267, United States
University Hospitals Cleveland Medical Center | Cleveland, Ohio, 44106, United States
Penn State University, The Milton S. Hershey Medical Center | Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania- Perelman Center for Advanced Medicine | Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania, 19107, United States
UPMC - Center for Liver Diseases at the Thomas E. Starlz Institute | Pittsburgh, Pennsylvania, 15213, United States
University Gastroenterology | Providence, Rhode Island, 02905, United States
Medical University of South Carolina, University Hospital | Charleston, South Carolina, 29425, United States
Greenville Health System Gastroenterology and Liver Center | Greenville, South Carolina, 29605, United States
WR-ClinSearch, LLC | Chattanooga, Tennessee, 37421, United States
Gastro One | Germantown, Tennessee, 38138, United States
Methodist University Hospital/University of Tennessee Health Science Center, Office of Clinical Research | Memphis, Tennessee, 38104, United States
Quality Medical Research PLLC | Nashville, Tennessee, 37211, United States
Vanderbilt University Medical Center - Digestive Disease Center | Nashville, Tennessee, 37232, United States
Texas Clinical Research Institute, LLC | Arlington, Texas, 76012, United States
Pinnacle Clinical Research, PLLC | Austin, Texas, 78746, United States
Austin Center for Clinical Research | Austin, Texas, 78756, United States
The Liver Institute at Methodist Dallas Medical Center | Dallas, Texas, 75203, United States
Texas Digestive Disease Consultants | Dallas, Texas, 75246, United States
Kelsey-Seybold Clinic | Houston, Texas, 77025, United States
Baylor College of Medicine - Advanced Liver Therapies | Houston, Texas, 77030, United States
Houston Methodist Hospital | Houston, Texas, 77030, United States
Liver Associates of Texas, P.A. | Houston, Texas, 77030, United States
Research Specialists of Texas | Houston, Texas, 77030, United States
Smith Clinic | Houston, Texas, 77030, United States
Pinnacle Clinical Research | Live Oak, Texas, 78233, United States
DHAT Research Institute | Richardson, Texas, 75082, United States
American Research Corporation, The Texas Liver Institute | San Antonio, Texas, 78215, United States
Intermountain Liver Disease and Transplant Clinic | Murray, Utah, 84107, United States
University of Utah | Salt Lake City, Utah, 84132, United States
The University of Vermont Medical Center | Burlington, Vermont, 05401, United States
University of Virginia Medical Center | Charlottesville, Virginia, 22908, United States
Inova Fairfax Medical Campus | Falls Church, Virginia, 22042, United States
Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia | Newport News, Virginia, 23226, United States
Digestive and Liver Disease Specialists | Norfolk, Virginia, 23502, United States
McGuire VA Medical Center | Richmond, Virginia, 23249, United States
Virginia Commonwealth University | Richmond, Virginia, 23298, United States
Virginia Mason | Seattle, Washington, 98101, United States
Swedish Organ Transplant and Liver Center | Seattle, Washington, 98104, United States
University of Washington | Seattle, Washington, 98195, United States
Royal Prince Alfred Hospital | Camperdown, New South Wales, 2050, Australia
St. Vincent's Hospital Sydney | Darlinghurst, New South Wales, 2010, Australia
St. George's Hospital | Kogarah, New South Wales, 2217, Australia
Westmead Hospital | Westmead, New South Wales, 2145, Australia
Royal Brisbane & Women's Hospital | Herston, Queensland, 4029, Australia
Royal Adelaide Hospital | Adelaide, South Australia, 5000, Australia
Lyell McEwin Hospital | Elizabeth Vale, South Australia, 5112, Australia
Monash Medical Centre | Clayton, Victoria, 3168, Australia
St. Vincent's Hospital Melbourne | Fitzroy, Victoria, 3065, Australia
Austin Health | Heidelberg, Victoria, 3081, Australia
The Alfred Hospital, Alfred Health | Melbourne, Victoria, 3004, Australia
Sir Charles Gairdner Hospital | Nedlands, Western Australia, 6009, Australia
Royal Perth Hospital | Perth, Western Australia, 6000, Australia
Medizinische Universitat Graz, Universitatsklinik fue Innere Medizin | Graz, A-8036, Austria
Allgemeines Krankenhaus Wien | Vienna, 1090, Austria
UZ Brussel | Brussels, 1090, Belgium
Cliniques Universitaires UCL Saint-Luc | Brussels, 1200, Belgium
CUB Hopital Erasme | Bruxelles, 10070, Belgium
Az Maria Middelares Ghent | Ghent, 9000, Belgium
UZ Leuven | Leuven, 3000, Belgium
University of Calgary Liver Unit (Heritage Medical Research Clinic) | Calgary, Alberta, T2N 4Z6, Canada
GI Research | Edmonton, Alberta, T5H 4B9, Canada
University of Alberta | Edmonton, Alberta, T6G 2R3, Canada
LAIR Centre | Vancouver, British Columbia, V5Z 1HZ, Canada
Gordon and Leslie Diamond Health Care Centre, Vancouver General Hospital, UBC Division of Gastroenterology | Vancouver, British Columbia, V5Z 1M9, Canada
PerCuro Clinical Research Ltd. | Victoria, British Columbia, V8T 5G4, Canada
University of Manitoba, Health Sciences Centre, John Buhler Research Centre | Winnipeg, Manitoba, R3E 3P4, Canada
South Shore Medical Arts | Bridgewater, Nova Scotia, B4V 3N2, Canada
William Osler Health System-Brampton Civic Hospital | Brampton, Ontario, L6R 3J7, Canada
St. Joseph's Healthcare Hamilton | Hamilton, Ontario, L8N 4A6, Canada
McMaster University Medical Centre | Hamilton, Ontario, L8S 4L8, Canada
London Health Sciences Centre - University Hospital | London, Ontario, N6A 5A5, Canada
Toronto Center for Liver Diseases (TCLD), Toronto General Hospital | Toronto, Ontario, M5G 2C4, Canada
Toronto Liver Centre | Toronto, Ontario, M6H 3M1, Canada
Chronic Viral Illness Service/Royal Victoria Hospital/McGill University Health Centre (MUHC) | Montréal, Quebec, H4A 3JI, Canada
CHU Amiens Picardie | Amiens, 80054, France
Centre Hospitalier Universitaire d'Angers | Angers, 49033, France
Centre Hospitalier Universitaire Estaing | Clermont-Ferrand, 63003, France
Hopital Henri Mondor | Créteil, 94010, France
CHU de Grenoble- Hopital Michallon | Grenoble, 38043, France
Centre Hospitalier Regional Universitaire- Hopital Claude Huriez | Lille, 59037, France
CHU de Limoges- Hopital Dupuytren- Federation Hepatologie | Limoges, 87042, France
Hopital de la Croix Rousse | Lyon, 69317, France
Hôpital Saint Joseph | Marseille, 13008, France
CHU de Montpellier, Hopital St Eloi | Montpellier, 34925, France
Centre Hospitalier Universitaire de Nice- Hopital l'Archet 2 | Nice, 06200, France
Hopital Cochin | Paris, 75014, France
Groupe Hospitalier Universitaire La Pitie Salpetriere | Paris, 75651, France
Hopital Beaujon | Pessac, 33600, France
Centre Hospitalier Universitaire de Strasbourg- Nouvel Hopital Civil | Strasbourg, 67091, France
Centre Hospitalier Universitaire de Toulouse- Hopital Purpan | Toulouse, 31059, France
Uniklinik RWTH Aachen, Medizinische Klinik III | Aachen, 52074, Germany
Universitatsklinikum Bonn (AoR) | Bonn, 53105, Germany
Universitatsklinikum Frankfurt der Goethe-Universitat | Frankfurt am main, 60590, Germany
Universitatsklinikum Leipzig AoR | Leipzig, 04103, Germany
Johannes Gutenberg-Universitat | Mainz, 55131, Germany
Prince of Wales Hospital | Sha Tin, Hong Kong
Alice Ho Miu Ling Nethersole Hospital | Tai Po, Hong Kong
Department of Hepatology PGIMER Chandigarh | Chandigarh, 160012, India
Global Clinical Reseaech Services PVT LTD | Hyderabad, 500004, India
Institute of Post Graduate Medical Education and Research (IPGMER) | Kolkata, 700020, India
Dayanand Medical College & Hospital | Ludhiana, 141001, India
Kasturba Medical College Hospital | Mangalore, 575001, India
Institute of Liver Diseases, HPB Surgery and Transplant Global Hospitals | Mumbai, 400012, India
Midas Multispecialty Hospital | Nagpur, 440010, India
All India Institute of Medical Sciences | New Delhi, 110029, India
Fortis Flt. Lt. Rajan Dhall Hospital | New Delhi, 110070, India
Institute of Liver & Biliary Sciences | New Delhi, 110070, India
Emek Medical Center | Afula, 18341, Israel
Rambam Health Care Campus | Haifa, 31096, Israel
The Lady Davis Carmel Medical Center | Haifa, 3436212, Israel
Shaare Zedek Medical Center | Jerusalem, 64239, Israel
Rabin Medical Center | Petaẖ Tiqwa, 49100, Israel
The Chaim Sheba Medical Center | Ramat Gan, 52621, Israel
Tel-Aviv Sourasky Medical Center | Tel Aviv, 64239, Israel
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico | Milan, 20122, Italy
IRCCS Istituto Clinico Humanitas | Rozzano, 20089, Italy
Fukui-Ken Saiseikai Hospital | Fukui, 918-8503, Japan
Kyushu University Hospital | Fukuoka, 812-8582, Japan
Hiroshima Red Cross Hospital & Atomic-bomb Survivors Hospital | Hiroshima, 730-8619, Japan
Juntendo University Shizuoka Hospital | Izunokuni, 410-2295, Japan
Kanazawa University Hospital | Kanazawa, 920-8641, Japan
Nara Medical University Hospital | Kashihara, 634-8522, Japan
Toranomon Hospital Kajigaya | Kawasaki, 105-8470, Japan
Kumamoto Shinto General Hospital | Kumamoto, 862-8655, Japan
Kurume University Hospital | Kurume, 830-0011, Japan
University Hospital, Kyoto Prefectural University of Medicine | Kyoto, 602-8566, Japan
Shinshu University Hospital | Matsumoto, 390-8621, Japan
Toranomon Hospital | Minato, 105-8470, Japan
Miyazaki Medical Center Hospital | Miyazaki, 880-0003, Japan
Aichi Medical University Hospital | Nagakute, 480-1195, Japan
Nara City Hospital | Nara, 630-8305, Japan
Kawasaki Medical School General Medical Center | Okayama, 700-8508, Japan
Okayama University Hospital | Okayama, 700-8558, Japan
Hirakata Kohsai Hospital | Osaka, 573-0153, Japan
Saga University Hospital | Saga, 849-8501, Japan
Hokkaido University Hospital | Sapporo, 060-8648, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Sapporo, 600033, Japan
Tokyo Womens Medical University Hospital | Shinjuku, 162-8666, Japan
Saiseikai Suita Hospital | Suita, 564-0013, Japan
Osaka University Hospital | Suita, 565-0871, Japan
Mie University Hospital | Tsu, 514-8507, Japan
Ehime University Hospital | Tōno, 7910295, Japan
Yamagata University Hospital | Yamagata, 990-9585, Japan
Yokohama City University Hospital | Yokohama, 236-0004, Japan
National Hospital Organization Nagasaki Medical Center | Ōmura, 856-8562, Japan
Keimyung University Dongsan Medical Center | Daegu, 41931, Korea, Republic of
Kyungpook National University Hospital | Daegu, 700-721, Korea, Republic of
National Health Insurance Service- Ilsan Hospital | Goyang-si, 10444, Korea, Republic of
Inha University Hospital | Incheon, 22332, Korea, Republic of
Seoul National University Bundang Hospital | Seongnam, 463-707, Korea, Republic of
Seoul National University Hospital | Seoul, 03830, Korea, Republic of
Asan Medical Center | Seoul, 05505, Korea, Republic of
SMG-SNU Boramae Medical Center | Seoul, 07061, Korea, Republic of
Gangnam Severance Hospital | Seoul, 135-720, Korea, Republic of
Korea University Guro Hospital | Seoul, 152-703, Korea, Republic of
Consultorio Médico | Mexico City, 6700, Mexico
Accelerium S. de R.L. de C.V. | Monterrey, 64000, Mexico
Auckland City Hospital | Auckland, 1023, New Zealand
Southern District Health Board - Dunedin Hospital | Dunedin, 9016, New Zealand
Szpital Specjalistyczny Nr 1 w Bytomiu, Oddzial Obserwacyjno-Zakazny i Hepatologii | Bytom, 41-902, Poland
ID Clinic Arkadiusz Pisula | Mysłowice, 41-400, Poland
Wojewodzki Specjalistyczny Szpital im. W. Bieganskiego | Łódź, 91-347, Poland
Klinical Investigations Group, LLC | San Juan, 00921, Puerto Rico
VA Carribean Healthcare System | San Juan, 00921, Puerto Rico
Fundacion de Investigacion de Diego | San Juan, 00927, Puerto Rico
National University Health System | Singapore, 169856, Singapore
Singapore General Hospital | Singapore, 169856, Singapore
Changi General Hospital Pte Ltd. | Singapore, 529889, Singapore
Hospital Universitario Fundacion Alcorcon | Alcorcón, 08036, Spain
Hospital Universitari Vall d'Hebron | Barcelona, 08035, Spain
Hospital Clinic de Barcelona | Barcelona, 08036, Spain
Hospital del Mar - Parc de Salut | Barcelona, 8003, Spain
Hospital Universitario La Paz | Madrid, 28046, Spain
Hospital Universitario Puerto de Hierro Majadahonda | Majadahonda, 28220, Spain
CHOP_Complejo Hospitalario Universitario de Pntevedra | Pontevedra, 36071, Spain
Hospital Universitario Marques de Valdecilla | Santander, 39008, Spain
Hospital Universitario Virgen del Rocio | Sevilla, 41013, Spain
Consorcio Hospital General Universitario de Valencia | Valencia, 46014, Spain
Hospital Universitari i Politecnic La Fe de Valencia | Valencia, 46026, Spain
Universitätsklinik für Viszerale Chirurgie und Medizin, Inselspital, Hepatologie | Bern, 3010, Switzerland
Istituto Cantanale di Patologia Locarno | Lugano, 6900, Switzerland
Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung, 80099, Taiwan
National Cheng Kung University Hospital | Tainan, 07428, Taiwan
National Taiwan University Hospital | Taipei, 10002, Taiwan
Chang Gung Medical Foundation-LinKou Branch | Taoyuan, 333, Taiwan
NHS Greater Glasgow and Clyde | Glasgow, G51 4TF, United Kingdom
Barts Health NHS Trust | London, E1 1BB, United Kingdom
King's College Hospital NHS Foundation Trust | London, SE5 9RS, United Kingdom
St. George's Hospital | London, SW170QT, United Kingdom
Imperial College Healthcare NHS Trust | London, W2YN1, United Kingdom
Nottingham University Hospitals NHS Trust | Nottingham, NG7 2UH, United Kingdom
Plymouth Hospitals NHS Trust | Plymouth, PL6 8DH, United Kingdom
Portsmouth Hospitals NHS Trust | Portsmouth, PO6 3LY, United Kingdom
Abertawe Bro Morgannwg University Health Board | Swansea, SA2 8QA, United Kingdom
Location Countries

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

United States

Verification Date

April 2020

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Arm group label: SEL 6 mg

Arm group type: Experimental

Description: Randomized Phase: SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks. Open-Label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.

Arm group label: SEL 18 mg

Arm group type: Experimental

Description: Randomized Phase: SEL 18 mg plus placebo to match SEL 6 mg for up to 240 weeks. Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.

Arm group label: Placebo

Arm group type: Placebo Comparator

Description: Randomized Phase: Placebo to match SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks. Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.

Acronym STELLAR-4
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Care Provider)

Source: ClinicalTrials.gov