- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04849728
Et fase 3-studie, der evaluerer langsigtet effektivitet og sikkerhed af Lanifibranor hos voksne patienter med (NASH) og fibrose 2 (F2)/fibrose 3 (F3) stadie af leverfibrose (NATiV3)
Et randomiseret, dobbeltblindt, placebokontrolleret, multicenter, fase 3-studie, der evaluerer langsigtet effektivitet og sikkerhed af Lanifibranor hos voksne patienter med ikke-cirrhotisk ikke-alkoholisk Steatohepatitis (NASH) og Fibrose 2 (F2)/Fibrose 3 (F3) ) Stadium af leverfibrose
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Primære mål
Dette fase 3-studie er udført for at evaluere lanifibranor hos voksne med NASH og leverfibrose stadie 2 eller 3 og består af 2 dele - Del 1 og Del 2, med følgende primære mål:
Del 1 At vurdere effekten af lanifibranor sammenlignet med placebo på NASH-opløsning og forbedring af fibrose vurderet ved leverhistologi.
Del 2 At vurdere effekten af lanifibranor sammenlignet med placebo på at forsinke NASH-sygdomsprogression målt ved et sammensat endepunkt, der inkluderer progression til cirrhose, leverrelaterede kliniske udfaldshændelser eller dødsfald af alle årsager.
Sekundære mål
Nøgle sekundære mål i del 1:
- At vurdere effekten af lanifibranor sammenlignet med placebo på NASH-opløsning og ingen forværring af fibrose
- At vurdere effekten af lanifibranor sammenlignet med placebo på forbedring af fibrose uden forværring af NASH
Andre sekundære mål for både del 1 og del 2:
- At vurdere effekten af lanifibranor sammenlignet med placebo på andre vigtige histologiske træk ved NASH
- At vurdere effekten af lanifibranor sammenlignet med placebo på NASH-opløsning og forbedring af fibrose hos diabetespatienter
- At vurdere effekten af lanifibranor sammenlignet med placebo på leverfunktionstests
- At vurdere effekten af lanifibranor sammenlignet med placebo på glykæmiske parametre
- At vurdere effekten af lanifibranor sammenlignet med placebo på lipidparametre
- At vurdere effekten af lanifibranor sammenlignet med placebo på leverstivhed
- At vurdere effekten af lanifibranor sammenlignet med placebo på sundhedsrelateret livskvalitet
- At vurdere langsigtet sikkerhed (op til 7 år) af lanifibranor
- At vurdere populations-PK-modellering af lanifibranor ved hjælp af sparsomt prøveudtagningsskema
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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-
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Buenos Aires, Argentina, C1280AEB
- Hospital Britanico de Buenos Aires
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Buenos Aires, Argentina, C1124AAD
- Hospital De Alta Complejidad en Red El Cruce
-
-
Buenos Aires
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
- Hospital Italiano de Buenos Aires
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La Plata, Buenos Aires, Argentina, B1900AXI
- Hospital Italiano La Plata
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Pilar, Buenos Aires, Argentina, B1629AHJ
- Hospital Universitario Austral
-
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2002KDS
- Hospital Provincial del Centenario
-
-
-
-
New South Wales
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Concord, New South Wales, Australien, 2139
- Concord Repatriation General Hospital
-
Liverpool, New South Wales, Australien, 2170
- Liverpool Hospital
-
Liverpool, New South Wales, Australien, 2170
- Campbelltown Hospital
-
Penrith, New South Wales, Australien, 2750
- Nepean Hospital
-
-
Queensland
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Greenslopes, Queensland, Australien, 4120
- Gallipoli Medical Research Foundation
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Herston, Queensland, Australien, 4029
- Royal Brisbane and Women's Hospital
-
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Victoria
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Box Hill, Victoria, Australien, 3128
- Eastern Health - Australia
-
Clayton, Victoria, Australien, 3168
- Monash Medical Centre
-
Heidelberg, Victoria, Australien, 3084
- Austin Health
-
-
Western Australia
-
Murdoch, Western Australia, Australien, 6150
- Fiona Stanley Hospital
-
Perth, Western Australia, Australien, 6000
- Royal Perth Hospital
-
-
-
-
-
Brussels, Belgien, 1200
- Cliniques universitaires Saint-Luc
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Liège, Belgien, B-4000
- Centre Hospitalier Universitaire de Liège Site Sart Tilman
-
-
Antwerpen
-
Edegem, Antwerpen, Belgien, 2650
- Universitair Ziekenhuis Antwerpen
-
-
Brussels Capital
-
Brussels, Brussels Capital, Belgien, 1070
- Hôpital Erasme
-
-
Flemish Brabant
-
Leuven, Flemish Brabant, Belgien, 3000
- Universitair Ziekenhuis Leuven - Campus Gasthuisberg
-
-
Limburg
-
Genk, Limburg, Belgien, 3600
- Ziekenhuis Oost-Limburg - Campus Sint-Jan
-
-
Oost-Vlaaderen
-
Ghent, Oost-Vlaaderen, Belgien, 9000
- Algemeen Ziekenhuis Maria Middelares
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, Belgien, 9000
- Universitair Ziekenhuis Gent
-
Sint-Niklaas, Oost-Vlaanderen, Belgien, 9100
- Vitaz
-
-
West-Vlaanderen
-
Roeselare, West-Vlaanderen, Belgien, 8800
- Algemeen Ziekenhuis Delta - Campus Rumbeke
-
-
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brasilien, 30130-100
- Hospital das Clinicas da Universidade Federal de Minas Gerais
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasilien, 90035-903
- Hospital de Clínicas de Porto Alegre
-
-
São Paulo
-
Cerqueira César, São Paulo, Brasilien, 05403-000
- Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
-
Ribeirão Preto, São Paulo, Brasilien, 14051-140
- Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto
-
São José do Rio Preto, São Paulo, Brasilien, 15090-000
- Fundação Faculdade Regional de Medicina de São José do Rio Preto
-
-
-
-
-
Sofia, Bulgarien, 1407
- Acibadem City Clinic Tokuda Hospital
-
Sofia, Bulgarien, 1431
- Diagnostic Consultative Center Aleksandrovska
-
Sofia, Bulgarien, 1618
- Diagnostic Consulting Center 20 - Sofia Еооd
-
Veliko Tarnovo, Bulgarien, 5006
- Medical Center Medica Plus
-
-
Sofia-Grad
-
Sofia, Sofia-Grad, Bulgarien, 1431
- University Multiprofile Hospital for Active Treatment St. Ivan Rilski
-
Sofia, Sofia-Grad, Bulgarien, 1612
- University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov
-
-
-
-
Alberta
-
Calgary, Alberta, Canada, T2N 4Z6
- Heritage Medical Research Centre
-
-
Ontario
-
Brampton, Ontario, Canada, L6R 3J7
- William Osler Health System - Brampton Civic Hospital
-
Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Healthcare Hamilton - Charlton Campus
-
Toronto, Ontario, Canada, M5G 2C4
- University Health Network
-
Vaughan, Ontario, Canada, L4L 4Y7
- Toronto Digestive Disease Associates
-
-
Quebec
-
Montreal, Quebec, Canada, H4A 3J1
- McGill University Health Centre
-
Terrebonne, Quebec, Canada, J6X 497
- Centre de Medecine Metabolique de Lanaudiere
-
-
-
-
-
Santiago, Chile, 8320000
- Pontificia Universidad Católica de Chile - Escuela de Medicina
-
-
Coquimbo Region
-
La Serena, Coquimbo Region, Chile, 1700000
- Hospital San Juan de Dios de La Serena
-
-
Valparaiso
-
Viña del Mar, Valparaiso, Chile, 2540364
- Centro de Investigaciones Clinicas Viña del Mar
-
-
-
-
-
London, Det Forenede Kongerige
- Royal Free London NHS Foundation Trust
-
-
England
-
London, England, Det Forenede Kongerige, SE5 9RS
- King's College Hospital NHS Foundation Trust
-
London, England, Det Forenede Kongerige, E1 1BB
- Barts Health NHS Trust
-
London, England, Det Forenede Kongerige, EN1 1LJ
- Panthera Biopartners - North London
-
Manchester, England, Det Forenede Kongerige, OL11 4AU
- Panthera Biopartners - Manchester
-
Manchester, England, Det Forenede Kongerige
- Panthera Biopartners - Manchester
-
Newcastle upon Tyne, England, Det Forenede Kongerige, NE7 7DN
- The Newcastle upon Tyne Hospitals NHS Foundation Trust
-
Nottingham, England, Det Forenede Kongerige
- Nottingham University Hospitals NHS Trust
-
Preston, England, Det Forenede Kongerige, PR2 9QB
- Panthera Biopartners - Preston
-
Sheffield, England, Det Forenede Kongerige
- Sheffield Teaching Hospitals NHS FT
-
Surrey Quays, England, Det Forenede Kongerige, GU2 7XX
- Royal Surrey County Hospital NHS Foundation Trust
-
-
North Lanarkshire
-
Glasgow, North Lanarkshire, Det Forenede Kongerige, G51 4TF
- Panthera Biopartners - Glasgow
-
-
-
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Alabama
-
Birmingham, Alabama, Forenede Stater, 35209
- Objective Health - Birmingham Gastroenterology Associates
-
Dothan, Alabama, Forenede Stater, 36305
- Digestive Health Specialist of the Southeast
-
Madison, Alabama, Forenede Stater, 60602
- North Alabama GI Research Center llc
-
-
Arizona
-
Chandler, Arizona, Forenede Stater, 85224-5688
- The Institute for Liver Health - Chandler
-
Peoria, Arizona, Forenede Stater, 85381
- Arizona Liver Health - Peoria
-
Phoenix, Arizona, Forenede Stater, 85013
- Saint Joseph's Hospital and Medical Center
-
Phoenix, Arizona, Forenede Stater, 85013
- Dignity Health - St. Joseph's Hospital and Medical Center
-
Tucson, Arizona, Forenede Stater, 85712
- Adobe Gastroenterology
-
Tucson, Arizona, Forenede Stater, 85712
- Arizona Liver Health
-
-
Arkansas
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Conway, Arkansas, Forenede Stater, 72032
- ARcare Center for Clinical Research - Conway
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Little Rock, Arkansas, Forenede Stater, 72205
- Arkansas Diagnostic Center
-
Little Rock, Arkansas, Forenede Stater, 72205
- ARcare Center for Clinical Research
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North Little Rock, Arkansas, Forenede Stater, 72117
- Arkansas Gastroenterology
-
North Little Rock, Arkansas, Forenede Stater, 72117
- Summit - Arkansas Gastroenterology
-
-
California
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Camarillo, California, Forenede Stater, 93011
- Fomatmedicalresearch
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Chula Vista, California, Forenede Stater, 91911
- Velocity Clinical Research, Chula Vista
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Chula Vista, California, Forenede Stater, 91910
- GW Research
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El Cajon, California, Forenede Stater, 92020
- TriWest Research Associates
-
Fountain Valley, California, Forenede Stater, 92708
- Cure Clinical Research, LLC
-
Garden Grove, California, Forenede Stater, 92844
- SC Clinical Research
-
Gardena, California, Forenede Stater, 90247
- Velocity Clinical Research - Gardena
-
Huntington Park, California, Forenede Stater, 92704
- National Research Institute - Santa Ana
-
Lancaster, California, Forenede Stater, 93534
- The Clinical Trials Network - Gastro Care Institute
-
Los Angeles, California, Forenede Stater, 90057
- National Research Institute - Westlake
-
Panorama City, California, Forenede Stater, 91402
- National Research Institute - Panorama City
-
Pasadena, California, Forenede Stater, 91105
- California Liver Reearch
-
Poway, California, Forenede Stater, 92064
- Cadena Care Institute
-
Redwood City, California, Forenede Stater, 94063
- Stanford University Medical Center
-
San Diego, California, Forenede Stater, 92111
- Research and Education, Inc.
-
San Francisco, California, Forenede Stater, 94115
- Quest Clinical Research
-
San Francisco, California, Forenede Stater, 64107
- California Pacific Medical Center Research Institute
-
San Jose, California, Forenede Stater, 95128
- Silicon Valley Research Institute
-
Thousand Oaks, California, Forenede Stater, 91360
- Clinical Trial Management Services
-
Van Nuys, California, Forenede Stater, 91405
- San Fernando Valley Health Institute
-
-
Colorado
-
Englewood, Colorado, Forenede Stater, 80113
- South Denver Gastroenterology - Swedish Medical Center Office
-
-
Connecticut
-
New Haven, Connecticut, Forenede Stater, 06520
- Yale School of Medicine
-
-
Florida
-
Bradenton, Florida, Forenede Stater, 34208
- Synergy Healthcare
-
Bradenton, Florida, Forenede Stater, 34209
- Florida Research Institute
-
Clearwater, Florida, Forenede Stater, 33761
- Tampa Bay Medical Research
-
Clearwater, Florida, Forenede Stater, 33762
- Gastro Florida
-
Coral Gables, Florida, Forenede Stater, 33134
- Hi Tech and Global Research, LLC
-
Cutler Bay, Florida, Forenede Stater, 33189
- Top Medical Research
-
Cutler Bay, Florida, Forenede Stater, 33189
- JY Research Institute Inc.
-
Hialeah, Florida, Forenede Stater, 33016
- Palmetto Research
-
Hialeah, Florida, Forenede Stater, 33016
- Doral Medical Research, LLC
-
Lakewood Rch, Florida, Forenede Stater, 34211
- Florida Research Institute
-
Lehigh Acres, Florida, Forenede Stater, 33936
- Galenus Group
-
Maitland, Florida, Forenede Stater, 32751
- Accel Research Sites
-
Maitland, Florida, Forenede Stater, 32751
- Centor for Advanced Gastroenterology - Main Office - Maitland
-
Miami, Florida, Forenede Stater, 33176
- Miami Dade Medical Research Institute
-
Miami, Florida, Forenede Stater, 33136
- Schiff Center for Liver Diseases
-
Miami, Florida, Forenede Stater, 33165
- Genoma Research Group
-
Miami, Florida, Forenede Stater, 33165
- Future Care Solution
-
Miami, Florida, Forenede Stater, 33155
- D&H National Research Centers
-
Miami, Florida, Forenede Stater, 33175
- Pro Live Medical Research
-
Miami, Florida, Forenede Stater, 33012
- Florida Vascular Research
-
Miami, Florida, Forenede Stater, 33122
- Life Medical Research Group
-
Miami, Florida, Forenede Stater, 33173
- Gastro Health - Galloway
-
Miami, Florida, Forenede Stater, 33181
- Clinical Trials Services Corporation
-
New Port Richey, Florida, Forenede Stater, 34653
- Advanced Research Institute
-
Ocoee, Florida, Forenede Stater, 34761
- Sensible Healthcare Clinical Research
-
Orlando, Florida, Forenede Stater, 32804
- AdventHealth Transplant Institute
-
Orlando, Florida, Forenede Stater, 32825
- Digestive and Liver Center of Florida - Orlando
-
Palmetto Bay, Florida, Forenede Stater, 33157
- IMIC Research - International Medical Investigations Centers
-
Pembroke Pines, Florida, Forenede Stater, 33027
- American Research Centers of Florida
-
Pensacola, Florida, Forenede Stater, 32503
- Pensacola GI Research Center
-
Plantation, Florida, Forenede Stater, 33317
- Eminat, LLC
-
Pompano Beach, Florida, Forenede Stater, 33064
- NAPA Research
-
Pompano Beach, Florida, Forenede Stater, 33064
- D & H Pompano Research Center
-
Sarasota, Florida, Forenede Stater, 34420
- Covenant Metabolic Specialists LLC - Sarasota
-
Tampa, Florida, Forenede Stater, 33606
- Tampa General Hospital
-
Weston, Florida, Forenede Stater, 33331
- Cleveland Clinic Florida
-
Zephyrhills, Florida, Forenede Stater, 33542
- Florida Medical Clinic - Zephyrhills
-
-
Georgia
-
Atlanta, Georgia, Forenede Stater, 30309
- Digestive Healthcare of Georgia
-
College Park, Georgia, Forenede Stater, 30349
- Oracle Clinical Research
-
Columbus, Georgia, Forenede Stater, 31904
- IACT Health
-
Dalton, Georgia, Forenede Stater, 30720
- Southeast Clinical Research Center
-
-
Idaho
-
Idaho Falls, Idaho, Forenede Stater, 83404
- Grand Teton Research Group, PLLC
-
-
Illinois
-
Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
-
Chicago, Illinois, Forenede Stater, 60611
- University of Chicago
-
Skokie, Illinois, Forenede Stater, 60077
- NorthShore University Healthsystem
-
-
Indiana
-
Hammond, Indiana, Forenede Stater, 46324
- ASHA Clinical Research - Munster
-
-
Iowa
-
Clive, Iowa, Forenede Stater, 50325
- Heartland Medical Research
-
Iowa City, Iowa, Forenede Stater, 52242
- University of Iowa Hospitals and Clinics
-
-
Kansas
-
Kansas City, Kansas, Forenede Stater, 66160
- University of Kansas Medical Center Research Institute
-
Kansas City, Kansas, Forenede Stater, 66160
- Arizona Digestive Health - Sun City
-
Topeka, Kansas, Forenede Stater, 66606
- Kansas Medical Clinic - Gastroenterology
-
-
Kentucky
-
Lexington, Kentucky, Forenede Stater, 40506-0032
- University of Kentucky
-
-
Louisiana
-
Houma, Louisiana, Forenede Stater, 70363
- Tandem Clinical Research GI
-
Lafayette, Louisiana, Forenede Stater, 70503
- Combined Gastro Research LLC
-
Marrero, Louisiana, Forenede Stater, 70072
- Tandem Clinical Research
-
Metairie, Louisiana, Forenede Stater, 70006
- Metropolitan Gastroenterology Associates - Metairie
-
Shreveport, Louisiana, Forenede Stater, 71103
- Louisiana Research Center LLC
-
-
Maryland
-
Baltimore, Maryland, Forenede Stater, 21287
- The Johns Hopkins Hospital
-
Baltimore, Maryland, Forenede Stater, 21202
- Mercy Medical Center - Mcauley Plaza
-
Catonsville, Maryland, Forenede Stater, 21228
- Digestive Disease Associates - Catonsville
-
Chevy Chase, Maryland, Forenede Stater, 20815
- Chevy Chase Clinical Research
-
Greenbelt, Maryland, Forenede Stater, 20770
- Mid-Atlantic GI Research
-
Hagerstown, Maryland, Forenede Stater, 21742
- Meritus Center for Clinical Research
-
-
Massachusetts
-
Boston, Massachusetts, Forenede Stater, 02114
- Massachusetts General Hospital
-
Boston, Massachusetts, Forenede Stater, 02118
- Boston Medical Center
-
Boston, Massachusetts, Forenede Stater, 02215
- Beth Israel Deaconess Medical Center - Liver Center
-
Fall River, Massachusetts, Forenede Stater, 02721
- NECCR Prima Care Research, LLC
-
-
Michigan
-
Chesterfield, Michigan, Forenede Stater, 48047
- Clinical Research Institute of Michigan
-
Detroit, Michigan, Forenede Stater, 48202
- Henry Ford Health System
-
Wyoming, Michigan, Forenede Stater, 49519
- Gastroenterology Associates of Western Michigan
-
-
Minnesota
-
Minneapolis, Minnesota, Forenede Stater, 55413
- MNGI Digestive Health - Northeast Minneapolis Clinic
-
Rochester, Minnesota, Forenede Stater, 55905
- Mayo Clinic - Rochester
-
-
Mississippi
-
Flowood, Mississippi, Forenede Stater, 39232
- Gastrointestinal Associates & Endoscopy Center - Flowood
-
-
Missouri
-
Chesterfield, Missouri, Forenede Stater, 63005
- Galen Research
-
Columbia, Missouri, Forenede Stater, 65201
- Gastrointestinal (GI) Associates L.L.P.
-
Kansas City, Missouri, Forenede Stater, 64131
- Kansas City Research Institute
-
St Louis, Missouri, Forenede Stater, 63110
- Washington University School of Medicine in St. Louis
-
-
Nevada
-
Las Vegas, Nevada, Forenede Stater, 89106
- Sierra Clinical Research - Las Vegas
-
-
New Mexico
-
Albuquerque, New Mexico, Forenede Stater, 87109
- Southwest Gastroenterology Associates
-
-
New York
-
Buffalo, New York, Forenede Stater, 14203
- State University of New York - University at Buffalo
-
New York, New York, Forenede Stater, 10029
- Icahn School of Medicine at Mount Sinai
-
New York, New York, Forenede Stater, 10021
- Weill Cornell Medical College
-
New York, New York, Forenede Stater, 10033
- Tandem Clinical Research - New York Clinic
-
New York, New York, Forenede Stater, 10016
- New York University Langone Gastroenterology Associates
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
-
Staten Island, New York, Forenede Stater, 10310
- Richmond University Medical Center
-
-
North Carolina
-
Charlotte, North Carolina, Forenede Stater, 28207
- Charlotte Gastroenterology and Hepatology - Randolph Road Office
-
Durham, North Carolina, Forenede Stater, 27710
- Duke University Medical Center
-
Durham, North Carolina, Forenede Stater, 27710
- Icahn School of Medicine at Mount Sinai
-
Fayetteville, North Carolina, Forenede Stater, 28304
- Cumberland Research Associates
-
Greenville, North Carolina, Forenede Stater, 27834
- Carolina Digestive Diseases
-
Morehead City, North Carolina, Forenede Stater, 28557
- Lucas Research, Inc
-
Winston-Salem, North Carolina, Forenede Stater, 27103
- Gastroenterology of the Piedmont, PA - Salem Office
-
-
Ohio
-
Cincinnati, Ohio, Forenede Stater, 45249
- Consultants for Clinical Research - Montgomery Office
-
Cleveland, Ohio, Forenede Stater, 44106
- University Hospitals Case Medical Center
-
Columbus, Ohio, Forenede Stater, 43201
- The Ohio State University
-
Columbus, Ohio, Forenede Stater, 43213
- Aventiv Research - Columbus
-
Columbus, Ohio, Forenede Stater, 43213
- Centricity (Aventiv) Research - Columbus
-
Dayton, Ohio, Forenede Stater, 45414
- Digestive Specialists - Dayton
-
Dublin, Ohio, Forenede Stater, 43016
- Ohio Gastroenterology Group, Inc. - Olentangy Office
-
Mentor, Ohio, Forenede Stater, 44060
- Great Lakes Gastroenterology Research - Mentor
-
Westlake, Ohio, Forenede Stater, 44145
- North Shore Gastroenterology
-
-
Oklahoma
-
Tulsa, Oklahoma, Forenede Stater, 74104
- Options Health Research
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Forenede Stater, 15261
- University of Pittsburgh Medical Center
-
Pittsburgh, Pennsylvania, Forenede Stater, 15240
- Veterans Affairs Pittsburgh Healthcare System - University Drive Campus
-
-
South Carolina
-
Charleston, South Carolina, Forenede Stater, 29425
- Medical University of South Carolina
-
Summerville, South Carolina, Forenede Stater, 29485
- Palmetto Clinical Research
-
West Columbia, South Carolina, Forenede Stater, 29169
- Clinovacare Medical Clinical Research Center
-
-
South Dakota
-
Rapid City, South Dakota, Forenede Stater, 57701
- Rapid City Medical Center
-
-
Tennessee
-
Germantown, Tennessee, Forenede Stater, 38138
- Gastro One - Germantown Office - Wolf Park Drive
-
Nashville, Tennessee, Forenede Stater, 37232
- Vanderbilt University Medical Center
-
-
Texas
-
Arlington, Texas, Forenede Stater, 76012
- Texas Clinical Research Institute
-
Austin, Texas, Forenede Stater, 78745
- Accelemed Research Institute
-
Brownsville, Texas, Forenede Stater, 78520
- South Texas Research Institute - Brownsville
-
Cedar Park, Texas, Forenede Stater, 78613
- Velocity Clinical Research - Austin
-
Dallas, Texas, Forenede Stater, 75203
- The Liver Institute at Methodist Dallas
-
Dallas, Texas, Forenede Stater, 75234
- Liver Center of Texas
-
Dallas, Texas, Forenede Stater, 75246
- GI Alliance - Texas Digestive Disease Consultants - Fort Worth - Downtown
-
Denison, Texas, Forenede Stater, 75020
- Soma Clinical Trials
-
Edinburg, Texas, Forenede Stater, 78539
- South Texas Research Institute - Edinburg
-
Forney, Texas, Forenede Stater, 75126
- Care United Medical Center - Forney
-
Fort Sam Houston, Texas, Forenede Stater, 78234
- Brooke Army Medical Center
-
Garland, Texas, Forenede Stater, 75044
- Digestive Health Associates of Texas - Rockwall
-
Houston, Texas, Forenede Stater, 77030
- Houston Methodist Hospital
-
Houston, Texas, Forenede Stater, 77030
- Liver Associates of Texas
-
Houston, Texas, Forenede Stater, 77099
- Pioneer Research Solutions
-
Houston, Texas, Forenede Stater, 77030
- Liver Specialists of Texas
-
Houston, Texas, Forenede Stater, 77079
- Houston Research Institute (HRI)
-
Live Oak, Texas, Forenede Stater, 78233
- Summit - Pinnacle Clinical Research - Austin
-
Lubbock, Texas, Forenede Stater, 79410
- GI Alliance - Lubbock Digestive Disease Associates - Lubbock
-
Mansfield, Texas, Forenede Stater, 76063
- GI Alliance - Mansfield
-
McAllen, Texas, Forenede Stater, 78504
- Koncord Research - McAllen LLC
-
McAllen, Texas, Forenede Stater, 78504
- Koncord Research-McAllen LLC
-
San Antonio, Texas, Forenede Stater, 78215
- Sun Research Institute
-
San Antonio, Texas, Forenede Stater, 78215
- Texas Liver Institute/American Research Corporation
-
San Antonio, Texas, Forenede Stater, 78229
- Pinnacle Clinical Research - San Antonio
-
San Antonio, Texas, Forenede Stater, 78209
- Quality Research - San Antonio
-
San Antonio, Texas, Forenede Stater, 78215
- University of California San Diego
-
Sherman, Texas, Forenede Stater, 75092
- Sherman Clinical Research
-
Sugar Land, Texas, Forenede Stater, 77478
- Olympus Clinical Research
-
Waco, Texas, Forenede Stater, 76710
- Impact Research Institute
-
Waco, Texas, Forenede Stater, 76712
- Digestive Health Research of Central Texas
-
Webster, Texas, Forenede Stater, 77598
- GI Alliance - Bay Area Gastroenterology - Webster
-
Wichita Falls, Texas, Forenede Stater, 76301
- Digestive Health Research of North Texas
-
-
Utah
-
Draper, Utah, Forenede Stater, 84020
- Lone Peak Family Health
-
Draper, Utah, Forenede Stater, 84020
- Physicians' Research Options LLC - Draper UT/Lone Peak Family Clinic
-
Salt Lake City, Utah, Forenede Stater, 84132
- University of Utah School of Medicine
-
-
Vermont
-
Burlington, Vermont, Forenede Stater, 05401
- University of Vermont Medical Center
-
-
Virginia
-
Charlottesville, Virginia, Forenede Stater, 22903
- University of Virginia Health System
-
Leesburg, Virginia, Forenede Stater, 20176
- Emeritas Research Group
-
Manassas, Virginia, Forenede Stater, 20110
- Topography Health, Inc.
-
Newport News, Virginia, Forenede Stater, 23602
- Bon Secours Liver Institute of Hampton Roads
-
Norfolk, Virginia, Forenede Stater, 23502
- Digestive & Liver Disease Specialists
-
Richmond, Virginia, Forenede Stater, 23284
- Virginia Commonwealth University
-
Richmond, Virginia, Forenede Stater, 23236
- GI Select Health Research, LLC
-
Richmond, Virginia, Forenede Stater, 23249
- Hunter Holmes Mcguire Veterans Affairs Medical Center - Richmond
-
-
Washington
-
Seattle, Washington, Forenede Stater, 98105
- Liver Institute Northwest
-
-
Wisconsin
-
Milwaukee, Wisconsin, Forenede Stater, 53226
- Froedtert and Medical College of Wisconsin
-
-
-
-
Auvergne-Rhône-Alpes
-
Lyon, Auvergne-Rhône-Alpes, Frankrig, 69317
- Hopital de la croix rousse
-
-
Bas-Rhin
-
Strasbourg, Bas-Rhin, Frankrig, 67200
- Hôpital Hautepierre
-
-
Bouches-du-Rhône
-
Marseille, Bouches-du-Rhône, Frankrig, 13008
- Höpital Saint-Joseph
-
-
Cantal
-
Dijon, Cantal, Frankrig
- CHU Dijon Bourgogne - Hopital Francois Mitterrand
-
-
Franche-Comté
-
Besançon, Franche-Comté, Frankrig, 25030
- CHRU de Besançon - Hôpital Jean-Minjoz
-
-
Hauts-de-France
-
Lille, Hauts-de-France, Frankrig, 59037
- CHU de LILLE - Hopital Claude Huriez
-
-
Ille-et-Vilaine
-
Rennes, Ille-et-Vilaine, Frankrig, 35033
- Centre Hospitalier Universitaire de Rennes
-
-
Isère
-
Grenoble, Isère, Frankrig, 38043
- Centre Hospitalier Universitaire Grenoble Alpes
-
-
Limousin
-
Limoges, Limousin, Frankrig, 87042
- CHU de Limoges
-
-
Loire Atlantique
-
Nantes, Loire Atlantique, Frankrig, 44903
- Centre Hospitalier Universitaire De Nantes - Hopital Nord Laennec
-
-
Lorraine
-
Vandœuvre-lès-Nancy, Lorraine, Frankrig, 54511
- Hopitaux de Brabois
-
Vandœuvre-lès-Nancy, Lorraine, Frankrig
- Hopitaux de Brabois
-
-
Maine-et-Loire
-
Angers, Maine-et-Loire, Frankrig, 49933
- Centre Hosptitalier Universitaire d'Angers
-
Angers, Maine-et-Loire, Frankrig
- Centre Hosptitalier Universitaire d'Angers
-
-
Nantes Cedex 1
-
Nantes, Nantes Cedex 1, Frankrig
- Centre Hospitalier Universitaire De Nantes - Hopital Nord Laennec
-
-
New Aquitaine
-
Pessac, New Aquitaine, Frankrig, 33604
- Hôpital Haut-Lévêque
-
Pessac, New Aquitaine, Frankrig
- Hôpital Haut-Lévêque
-
-
Occitanie
-
Montpellier, Occitanie, Frankrig, 34295
- CHU Saint-Eloi
-
Toulouse, Occitanie, Frankrig, 31059
- Hôpital Rangueil
-
Toulouse, Occitanie, Frankrig, 31076
- Clinique Pasteur
-
-
Provence-Alpes-Côte d'Azur Region
-
Nice, Provence-Alpes-Côte d'Azur Region, Frankrig, 06200
- Hôpital l'Archet
-
-
Puy-de-Dôme
-
Clermont-Ferrand, Puy-de-Dôme, Frankrig, 63003
- Centre Hospitalier Universitaire Estaing
-
-
Île-de-France Region
-
Clichy, Île-de-France Region, Frankrig, 92118
- Hôpitaux Universitaires Paris Nord Val-de-Seine - Hôpital Beaujon
-
Créteil, Île-de-France Region, Frankrig, 94000
- Hôpitaux Universitaires Henri Mondor
-
Paris, Île-de-France Region, Frankrig, 75013
- Hopital Universitaire Pitie Salpetriere
-
Paris, Île-de-France Region, Frankrig, 75571
- Hôpital Saint-Antoine
-
Villejuif, Île-de-France Region, Frankrig, 94804
- Hôpitaux Universitaires Paris-Sud - Hôpital Paul Brousse
-
-
-
-
-
Rotterdam, Holland
- Franciscus Gasthuis & Vlietland
-
Utrecht, Holland, 3584 CX
- Universitair Medisch Centrum Utrecht
-
-
North Brabant
-
Tilburg, North Brabant, Holland, 5000 LC
- Elisabeth-Tweesteden Ziekenhuis
-
-
North Brabent
-
Uden, North Brabent, Holland, 5400
- Ziekenhuis Bernhoven
-
-
North Holland
-
Amsterdam, North Holland, Holland, 1081 HV
- Amsterdam Universitair Medische Centra - Vrije Universiteit Medisch Centrum
-
-
South Holland
-
Rotterdam, South Holland, Holland, 3015 GD
- Erasmus Medisch Centrum
-
-
-
-
-
Haifa, Israel, 3109601
- Rambam Health Care Campus
-
Tel Aviv, Israel, 69710
- The Chaim Sheba Medical Center
-
-
Gush Dan
-
Tel Aviv, Gush Dan, Israel, 64239
- Tel Aviv Sourasky Medical Center
-
-
Haifa District
-
Haifa, Haifa District, Israel, 3436212
- Carmel Medical Center
-
-
Jerusalem
-
Jerusalem, Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
-
Jerusalem, Jerusalem, Israel, 9112001
- Hadassah University Hospital Ein Kerem
-
-
Northern District
-
Nahariya, Northern District, Israel, 22100
- Western Galilee Hospital-Nahariya
-
-
Southern District
-
Beersheba, Southern District, Israel, 84101
- Soroka Medical Center
-
-
Tel Aviv
-
Ramat Gan, Tel Aviv, Israel, 52621
- The Chaim Sheba Medical Center
-
-
-
-
-
Bologna, Italien
- Azienda Ospedaliero-Universitaria di Bologna Policlinico Sant Orsola-Malpighi
-
Milan, Italien, 20122
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
-
Naples, Italien
- Università Degli Studi Di Napoli Federico Ii
-
Novara, Italien, 28100
- Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
-
Palermo, Italien
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
-
Roma, Italien
- Fondazione Policlinico Universitario Agostino Gemelli Irccs
-
Roma, Italien
- UOSD Interdipartimentale Degenza Medica a ciclo breve
-
Torino, Italien, 10126
- Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
-
-
Foggia
-
San Giovanni Rotondo, Foggia, Italien, 71013
- Ospedale Casa Sollievo della Sofferenza
-
-
Milan
-
Milan, Milan, Italien, 20162
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
-
-
-
-
-
Changchun, Kina
- The First Hospital of Jilin University
-
Changsha, Kina
- Xiangya Hospital - Central South University
-
Chengdu, Kina
- West China Hospital Sichuan University
-
Chongqing, Kina
- The Second Affiliated Hospital of Chongqing Medical University
-
Fuzhou, Kina
- Mengchao Hepatobiliary Hospital of Fujian Medical University
-
Guangzhou, Kina
- Guangdong Provincial People's Hospital
-
Guangzhou, Kina
- The Third Affiliated Hospital, Sun Yat-sen University
-
Hangzhou, Kina
- Sir Run Run Shaw Hospital of Zhejiang University School of Medicine - Qingchun Campus
-
Heping, Kina
- General Hospital of Tianjin Medical University
-
Ningbo, Kina
- Ningbo No.2 Hospital (Hwa Mei Hospital)
-
Qingdao, Kina
- Qingdao Municipal Hospital
-
Shanghai, Kina
- Ruijin Hospital, Shanghai JiaoTong University School of Medicine
-
Shenyang, Kina
- Shengjing Hospital Of China Medical University
-
Shenzhen, Kina
- The University of Hong Kong-Shenzhen Hospital
-
Tianjin, Kina
- Tianjin Third Central Hospital
-
Zhengzhou, Kina
- The First Affiliated Hospital of Zhengzhou University
-
Zhengzhou, Kina
- Zhengzhou People's Hospital
-
-
Anhui
-
Hefei, Anhui, Kina, 230022
- The First Affiliated Hospital of Anhui Medical University
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, Kina
- Peking University People's Hospital
-
Beijing, Beijing Municipality, Kina
- Peking University First Hospital
-
Beijing, Beijing Municipality, Kina
- Beijing Ditan Hospital, Capital Medical University
-
Beijing, Beijing Municipality, Kina, 100010
- Beijing Ditan Hospital Capital Medical University
-
-
Chongging
-
Chongqing, Chongging, Kina
- Chongqing University Three Gorges Hospital
-
Chongqing, Chongging, Kina
- First Affiliated Hospital of the Army Military Medical University (Southwest Hospital)
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, Kina
- The First Affiliated Hospital of Chongqing Medical University
-
-
Fengtai
-
Beijing, Fengtai, Kina
- Beijing You'an Hospital,Capital Medical University
-
-
Fujian
-
Fuzhou, Fujian, Kina
- The First Affiliated Hospital of Fujian Medical University
-
-
Gansu
-
Lanzhou, Gansu, Kina
- The First Hospital of Lanzhou University
-
-
Guangdong
-
Guangzhou, Guangdong, Kina
- Guangzhou First People's Hospital
-
Guangzhou, Guangdong, Kina
- Nanfang Hospital of Southern Medical University
-
Guangzhou, Guangdong, Kina
- The First Affiliated Hospital Sun Yat-Sen University
-
Guangzhou, Guangdong, Kina
- The Eighth Affiliated Hospital,GuangZhou Medical University
-
Shenzhen, Guangdong, Kina, 518036
- Peking University Shenzhen Hospital
-
-
Guangxi
-
Nanning, Guangxi, Kina
- The First Affiliated Hospital of Guangxi Medical University
-
-
Guizhou
-
Guiyang, Guizhou, Kina
- Guizhou Provincial People's Hospital
-
Guiyang, Guizhou, Kina
- The Affiliated Hospital of Guizhou Medical University
-
-
Hebei
-
Shijiazhuang, Hebei, Kina, 050052
- The Third Hospital of Hebei Medical University
-
-
Heilongjiang
-
Harbin, Heilongjiang, Kina, 150036
- Heilongjiang Provincial Hospital
-
Harbin, Heilongjiang, Kina
- Fourth Affiliated Hospital of Harbin Medical University
-
-
Henan
-
Luoyang, Henan, Kina
- The First Affiliated Hospital of Henan University of Science and Technology
-
Sanmenxia, Henan, Kina
- Sanmenxia Central Hospital
-
Xinxiang, Henan, Kina, 453000
- The Third Affiliated Hospital of Xinxiang Medical University
-
Zhengzhou, Henan, Kina
- The Sixth People's Hospital of Zhengzhou
-
Zhengzhou, Henan, Kina
- Zhengzhou First People's Hospital
-
Zhengzhou, Henan, Kina
- Henan Provincal People's Hospital
-
-
Hubei
-
Wuhan, Hubei, Kina
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
-
-
Hunan
-
Changsha, Hunan, Kina, 410699
- The Second Xiangya Hospital of Central South University
-
Yueyang, Hunan, Kina, 414000
- Yue Yang Central Hospital
-
-
Jiangsu
-
Nanjing, Jiangsu, Kina, 210008
- Nanjing Drum Tower Hospital
-
Nanjing, Jiangsu, Kina
- The Second Hospital of Nanjing
-
Nanjing, Jiangsu, Kina
- Jiangsu Provincial People's Hospital
-
Nantong, Jiangsu, Kina
- Affiliated Hospital of Nantong University
-
Suzhou, Jiangsu, Kina
- The Fifth People's Hospital of Suzhou
-
Wuxi, Jiangsu, Kina
- Wuxi No.5 People's Hospital
-
Zhenjiang, Jiangsu, Kina
- Third People's Hospital of Zhenjiang
-
-
Jiangxi
-
Nanchang, Jiangxi, Kina, 330006
- The First Affiliated Hospital of Nanchang University
-
Nanchang, Jiangxi, Kina
- The Second Affiliated Hospital of Nanchang University
-
-
Liaoning
-
Shenyang, Liaoning, Kina
- First Affiliated Hospital of China Medical University
-
Shenyang, Liaoning, Kina
- The Sixth People' s Hospital Of ShenYang
-
-
Shaanxi
-
Xi'an, Shaanxi, Kina
- Xi'an International Medical Center
-
Xi'an, Shaanxi, Kina, 710126
- Xi'an International Medical Center
-
-
Shandong
-
Jinan, Shandong, Kina, 250012
- Qilu Hospital of Shandong University
-
Qingdao, Shandong, Kina
- Qingdao Central Hospital
-
-
Shanxi
-
Taiyuan, Shanxi, Kina
- Xu, Jun The First Hospital of Shanxi Medical University Taiyun Shanxi
-
Xi’an, Shanxi, Kina
- The First Affiliated Hospital of Xi'an Jiaotong University
-
-
Sichuan Shi
-
Chengdu, Sichuan Shi, Kina
- Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
-
-
Yunnan
-
Kunming, Yunnan, Kina
- The First People's Hospital of Yunnan Province
-
-
Zhejiang
-
Hangzhou, Zhejiang, Kina
- The First Affiliated Hospital , Zhejiang University School of Medicine
-
Ruian, Zhejiang, Kina
- RuiAn People's Hospital - Ruixiang Branch
-
Wenzhou, Zhejiang, Kina
- The First Affiliated Hospital of Wenzhou Medical University
-
Yiwu, Zhejiang, Kina, 322000
- Yiwu Central Hospital
-
-
-
-
-
Metepec, Mexico
- Consultorio de la Dra. Maria Sarai Gonzalez Huezo
-
Metepec, Mexico
- Instituto de Seguridad Social del Estado de Mexico y Municipios
-
Metepec, Mexico
- Oaxaca Site Management Organization S.C.
-
Mexico City, Mexico
- Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ)
-
Mexico City, Mexico
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
-
Mexico City, Mexico, 03330
- Centro de Investigacion y Gastroenterologia, S.C.
-
Monterrey, Mexico
- Hospital Universitario Dr. Jose Eleuterio Gonzalez
-
Monterrey, Mexico
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez" (Servicio de Gastroenterologia)
-
Monterrey, Mexico
- Hospital Universitario "Dr. José Eleuterio González" (Servicio de Endocrinología)
-
Oaxaca City, Mexico
- Oaxaca Site Management Organization S.C.
-
Zumpango, Mexico
- Hospital Regional de Alta Especialidad de Zumpango
-
-
Jalisco
-
Guadalajara, Jalisco, Mexico
- Centro de investigacion medico biologica y terapia avanzada
-
-
Mexico City
-
Cuauhtémoc, Mexico City, Mexico, 06700
- Centro de Investigación y Gastroenterología
-
Mexico City, Mexico City, Mexico, 7760
- Organismo Publico Descentralizado Hospital Juarez de Mexico
-
-
Morelos
-
Cuernavaca, Morelos, Mexico
- PanAmerican Clinical Research Mexico - Cuernavaca
-
-
Nuevo León
-
Monterrey, Nuevo León, Mexico, 64460
- Hospital Universitario Doctor José Eleuterio Gonzalez
-
Monterrey, Nuevo León, Mexico, 64000
- Investigaciones Médicas Cisneros
-
-
Yucatán
-
Mérida, Yucatán, Mexico, 97070
- Medical Care and Research S.A. de C.V.
-
-
-
-
-
Gdansk, Polen, 80-382
- Synexus Polska Sp. z o.o. Oddzial w Gdansku
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polen, 60-702
- Synexus - Poznań
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polen, 50-381
- Synexus - Wrocław
-
Wroclaw, Lower Silesian Voivodeship, Polen, 51-162
- Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polen, 01-192
- Synexus - Warszawa
-
-
Pomeranian Voivodeship
-
Gdynia, Pomeranian Voivodeship, Polen, 81-537
- Synexus - Gdynia
-
-
Silesian Voivodeship
-
Częstochowa, Silesian Voivodeship, Polen, 42-202
- Synexus - Częstochowa
-
Katowice, Silesian Voivodeship, Polen, 40-040
- Synexus - Katowice
-
Katowice, Silesian Voivodeship, Polen, 40-081
- Centrum Medyczne Pratia - Katowice
-
Mysłowice, Silesian Voivodeship, Polen, 41-400
- ID Clinic
-
-
Łódź Voivodeship
-
Lodz, Łódź Voivodeship, Polen, 90-127
- Synexus - Łódź
-
-
-
-
-
Braga, Portugal, 4710-243
- Hospital de Braga
-
Lisbon, Portugal, 1649-035
- Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria
-
Porto, Portugal, 4200-319
- Centro Hospitalar Universitario de Sao Joao
-
Senhora da Hora, Portugal, Senhora Da Hora
- Hospital Pedro Hispano
-
Vila Real, Portugal
- Centro Hospitalar de Trás-Os-Montes e Alto-Douro - Hospital de S. Pedro
-
-
Braga District
-
Guimarães, Braga District, Portugal, 4835-044
- Hospital da Senhora da Oliveira - Guimarães
-
-
-
-
-
San Juan, Puerto Rico, 00927
- Fundación de Investigación de Diego Clinical Research
-
-
Pureto Rico
-
Manati, Pureto Rico, Puerto Rico, 00674
- Galenus Group of Pureto Rico
-
-
-
-
-
Almería, Spanien, 04009
- Complejo Hospitalario Torrecárdenas
-
Badalona, Spanien, 08916
- Hospital Germans Trias I Pujol
-
Barcelona, Spanien, 08036
- Hospital Clinic De Barcelona
-
Barcelona, Spanien, 08025
- Hospital De La Santa Creu I Sant Pau
-
Barcelona, Spanien, 08035
- Hospital Universitari Vall d'Hebron
-
León, Spanien, 24080
- Complejo Asistencial Universitario de Leon
-
Madrid, Spanien, 28007
- Hospital General Universitario Gregorio Marañon
-
Madrid, Spanien, 28027
- Clinica Universidad de Navarra
-
Pontevedra, Spanien, 36004
- Complejo Hospitalario de Pontevedra
-
Seville, Spanien, 41011
- Hospital Universitario Virgen del Rocio
-
Valencia, Spanien, 46010
- Hospital Clinico Universitario de Valencia
-
Valencia, Spanien, 46014
- Consorci Hospital General Universitari de València
-
Valladolid, Spanien, 47012
- Hospital Universitario Rio Hortega
-
Zaragoza, Spanien, 50009
- Hospital Clinico Universitario Lozano Blesa
-
Zaragoza, Spanien, 50009
- Hospital Universitario Miguel Servet
-
-
Balearic Islands
-
Palma de Mallorca, Balearic Islands, Spanien, 07120
- Hospital Universitario Son Espases
-
-
Barcelona
-
Sabadell, Barcelona, Spanien, 08208
- Consorci Corporació Sanitària Parc Taulí de Sabadell
-
-
Madrid
-
Majadahonda, Madrid, Spanien, 28222
- Hospital Universitario Puerta de Hierro - Majadahonda
-
-
-
-
-
Pretoria, Sydafrika, 0184
- Synexus Clinical Research SA- Watermeyer
-
-
Gauteng
-
Kempton Park, Gauteng, Sydafrika, 1619
- Clinresco Centres
-
Pretoria, Gauteng, Sydafrika, 184
- Synexus Clinical Research SA- Watermeyer
-
-
Western Cape
-
Cape Town, Western Cape, Sydafrika, 7800
- Synexus - Mediclinic Southern Africa - Constantiaberg
-
Cape Town, Western Cape, Sydafrika, 7130
- CTN (Clinical Trials Network): Somerset
-
Somerset West, Western Cape, Sydafrika, 7130
- Synexus - Helderberg Clinical Research Centre - Somerset West
-
-
-
-
-
Prague, Tjekkiet, 120 00
- Synexus Czech - DRS Prague
-
-
-
-
-
Berlin, Tyskland, 13353
- Charité Universitätsmedizin Berlin
-
Berlin, Tyskland, 10825
- Gastroenterologie am Bayerischen Platz
-
Berlin, Tyskland, 10787
- EPIMED
-
Cologne, Tyskland
- Uniklinik Köln
-
Northeim, Tyskland
- Universitätsklinikum Düsseldorf
-
-
Hesse
-
Wiesbaden, Hesse, Tyskland, 65189
- St. Josefs-Hospital Wiesbaden
-
-
Rhineland-Palatinate
-
Mainz, Rhineland-Palatinate, Tyskland, 55131
- Universitätsmedizin der Johannes Gutenberg-Universität Mainz
-
-
Saarland
-
Homburg, Saarland, Tyskland, 66421
- Universitätsklinikum des Saarlandes
-
-
Saxony
-
Chemnitz, Saxony, Tyskland, 09116
- Klinikum Chemnitz
-
Dresden, Saxony, Tyskland, 01307
- Universitätsklinikum Carl Gustav Carus Dresden
-
Leipzig, Saxony, Tyskland, 04103
- EUGASTRO
-
-
Schleswig-Holstein
-
Lübeck, Schleswig-Holstein, Tyskland
- Universitatsklinikum Schleswig-Holstein - Campus Lubeck
-
-
-
-
-
Kyiv, Ukraine, 3037
- Medical Center Medbud-Clinic, LLC
-
Kyiv, Ukraine, 4210
- Medical Center Center of Family Medicine Plus, LLC
-
-
-
-
-
Budapest, Ungarn, 1064
- High Tech Medical Kft.
-
Budapest, Ungarn, 1024
- MIND Klinika
-
-
Central Hungary
-
Budapest, Central Hungary, Ungarn, 1036
- SYNEXUS Magyarország Egészségügyi Szolgáltató KFT
-
-
Hajdú-Bihar
-
Debrecen, Hajdú-Bihar, Ungarn, 4031
- Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus
-
Debrecen, Hajdú-Bihar, Ungarn, 4025
- Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Mand eller kvinde, alderen ≥18 år på tidspunktet for underskrivelse af informeret samtykke
Ved central biopsiaflæsningsproces: diagnose af NASH i henhold til Steatosis-Activity-Fibrosis (SAF):
- Steatosescore ≥1
- Aktivitetsscore: A3 eller A4
- Fibrose-score: F2 eller F3
Stabil dosis for lægemidlerne anført nedenfor:
- Antidiabetisk behandling hvis glukagon-lignende peptid-1-receptoragonister (GLP1-receptoragonister) eller natrium-glucose co-transporter-2-hæmmere (SGLT2-hæmmere): Stabil dosis i mindst 3 måneder
- Vitamin E (hvis i en dosis ≥400 IE/dag): Stabil dosis i mindst 6 måneder
- Statiner: Stabil dosis i mindst 3 måneder
- Alle andre kronisk administrerede lægemidler skal være stabile i mindst 3 måneder før screening
- Vægtstabil i 6 måneder før screening og mellem den kvalificerende leverbiopsi og baseline (ikke mere end 5 % ændring for begge perioder)
- Negativ serumgraviditetstest ved undersøgelse Screening for kvinder i den fødedygtige alder bekræftet af centralt laboratorium. Kvinder i den fødedygtige alder skal praktisere en konsekvent og korrekt brug af højeffektiv præventionsmetode gennem hele undersøgelsen og i 1 måned efter behandlingsophør.
Ekskluderingskriterier:
Leverrelateret:
- Dokumenterede årsager til kronisk leversygdom bortset fra NASH
- Histologisk dokumenteret levercirrhose (fibrosestadie F4)
- Anamnese eller nuværende diagnose af hepatocellulært karcinom HCC
- Historie om eller planlagt levertransplantation
- Serologi af positiv human immundefektvirus (HIV).
- ALT eller AST >5 × ULN
- Unormal syntetisk leverfunktion som defineret ved screening centrallaboratorieevaluering
- Hæmoglobin <110 g/L (11 g/dL) for kvinder og <120 g/L (12 g/dL) for mænd
- Patient, der i øjeblikket modtager enhver godkendt behandling for NASH eller fedme
- Aktuel eller nyere historie (<5 år) med betydeligt alkoholforbrug
Behandling med lægemidler, der kan forårsage ikke-alkoholisk fedtleversygdom (NAFLD) administreret i mindst 2 uger inden for 12 måneder forud for kvalificerende leverbiopsi
Glykæmi relateret:
- HbA1c >9 % ved screening
- Anden diabetes mellitus end type 2
- Nuværende behandling med insulin
Tidligere eller nuværende behandling med PPAR-gamma-agonister (thiazolidindioner [TZD'er])
Fedme relateret:
Fedmekirurgi: Restriktive procedurer er tilladt, hvis de udføres >6 måneder før den kvalificerende leverbiopsi; malabsorptive procedurer og procedurer, der kombinerer både restriktive og malabsorptive metoder, er ikke tilladt inden for 5 år efter den kvalificerende leverbiopsi.
Kardiovaskulært relateret:
- Anamnese med hjertesvigt med reduceret venstre ventrikulær ejektionsfraktion (LVEF)
- Atrieflimren kræver antikoagulering
- Ustabilt hjertesvigt
Ukontrolleret hypertension ved screening (værdier >160/100 mm Hg)
Generel sikkerhed:
- Kvinder, der i øjeblikket ammer
- Tidligere eksponering for lanifibranor
- Deltagelse i ethvert forsøgslægemiddel/udstyr til kliniske forsøg inden for 3 måneder fra screening eller 5 halveringstider fra screening, alt efter hvad der er længst
- Samtidig behandling med PPAR-alfa-agonister (fibrater)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Lanifibranor (IVA 337) (800 mg/dag)
2 Lanifibranor tabletter 400mg + 1 placebo til at matche tablet med mad --> en gang dagligt (quaque die, QD)
|
I alt 1000 patienter vil blive randomiseret til at modtage henholdsvis lanifibranor (800 mg/dag) eller lanifibranor (1200 mg/dag) eller matchende placebo ved at anvende et 1:1:1 randomiseringsskema uden afbrydelse mellem del A og del B. .
Andre navne:
I alt 1000 patienter vil blive randomiseret til at modtage henholdsvis lanifibranor (800 mg/dag) eller lanifibranor (1200 mg/dag) eller matchende placebo ved at anvende et 1:1:1 randomiseringsskema uden afbrydelse mellem del A og del B. .
|
|
Eksperimentel: Lanifibranor (IVA 337) (1200 mg/dag)
3 Lanifibranor tabletter 400mg med mad --> en gang dagligt (quaque die, QD)
|
I alt 1000 patienter vil blive randomiseret til at modtage henholdsvis lanifibranor (800 mg/dag) eller lanifibranor (1200 mg/dag) eller matchende placebo ved at anvende et 1:1:1 randomiseringsskema uden afbrydelse mellem del A og del B. .
Andre navne:
|
|
Placebo komparator: Matchende placebo
3 placebo til at matche tabletter med mad --> en gang dagligt (quaque die, QD)
|
I alt 1000 patienter vil blive randomiseret til at modtage henholdsvis lanifibranor (800 mg/dag) eller lanifibranor (1200 mg/dag) eller matchende placebo ved at anvende et 1:1:1 randomiseringsskema uden afbrydelse mellem del A og del B. .
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Opløsning af NASH og forbedring af fibrose
Tidsramme: Del A: Dato for randomisering indtil datoen for biopsi i uge 72
|
Del A: DBPC: Opløsning af NASH og forbedring af fibrose i uge 72, defineret ved NASH CRN-score for ballondannelse på 0 og inflammation på 0 til 1, og fibrose-score ≥1 stadiefald sammenlignet med baseline
|
Del A: Dato for randomisering indtil datoen for biopsi i uge 72
|
|
Sikkerhedsanalyser
Tidsramme: 48 uger efter afslutning af DBPC-periode
|
Del B: ATE:
|
48 uger efter afslutning af DBPC-periode
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Arun J Sanyal, MD, VCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USA
- Ledende efterforsker: Sven Francque, MD, Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 337HNAS20011
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
produkt fremstillet i og eksporteret fra U.S.A.
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Chandan SenIndiana University; Malaysia Palm Oil BoardAktiv, ikke rekrutterendeSlutstadie leversygdom | NASH - Ikke-alkoholisk Steatohepatitis | NAFLD - Nonalcoholic Fatty Lever DiseaseForenede Stater
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Milton S. Hershey Medical CenterAfsluttetDyrke motion | NASH - Ikke-alkoholisk Steatohepatitis | NASH | LeverForenede Stater
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Assistance Publique - Hôpitaux de ParisIkke rekrutterer endnuFibrose | Cirrhose | NAFLD | NASH - Ikke-alkoholisk Steatohepatitis | NASH
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Corcept TherapeuticsRekrutteringIkke-alkoholisk Steatohepatitis (NASH) | Ikke-alkoholisk fedtleversygdom (NAFLD) | Metabolisk dysfunktion-associeret steatotisk leversygdom (MASLD) | Metabolisk dysfunktion-associeret steatohepatitis (MASH) / ikke-alkoholisk steatohepatitis (NASH) med kompenseret skrumpeleverForenede Stater
Kliniske forsøg med IVA337
-
Inventiva PharmaAfsluttetSklerodermi, diffus | Diffus kutan systemisk skleroseDet Forenede Kongerige, Frankrig, Spanien, Schweiz, Italien, Slovenien, Holland, Tyskland, Bulgarien, Polen
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Inventiva PharmaAfsluttetDiabetes mellitus, type 2 | NASH - Ikke-alkoholisk SteatohepatitisForenede Stater, Belgien, Frankrig, Holland, Det Forenede Kongerige