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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)

18. maj 2026 opdateret af: Inventiva Pharma

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

Dette fase 3-studie er udført for at evaluere lanifibranor hos voksne med NASH og leverfibrose stadium 2 eller 3

Studieoversigt

Status

Aktiv, ikke rekrutterende

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

Interventionel

Tilmelding (Anslået)

1000

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico de Buenos Aires
      • Buenos Aires, Argentina, C1124AAD
        • Hospital De Alta Complejidad en Red El Cruce
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, C1199ABB
        • Hospital Italiano de Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1900AXI
        • Hospital Italiano La Plata
      • Pilar, Buenos Aires, Argentina, B1629AHJ
        • Hospital Universitario Austral
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2002KDS
        • Hospital Provincial del Centenario
    • New South Wales
      • 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
      • Greenslopes, Queensland, Australien, 4120
        • Gallipoli Medical Research Foundation
      • Herston, Queensland, Australien, 4029
        • Royal Brisbane and Women's Hospital
    • Victoria
      • 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
      • 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
    • 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
      • Conway, Arkansas, Forenede Stater, 72032
        • ARcare Center for Clinical Research - Conway
      • Little Rock, Arkansas, Forenede Stater, 72205
        • Arkansas Diagnostic Center
      • Little Rock, Arkansas, Forenede Stater, 72205
        • ARcare Center for Clinical Research
      • North Little Rock, Arkansas, Forenede Stater, 72117
        • Arkansas Gastroenterology
      • North Little Rock, Arkansas, Forenede Stater, 72117
        • Summit - Arkansas Gastroenterology
    • California
      • Camarillo, California, Forenede Stater, 93011
        • Fomatmedicalresearch
      • Chula Vista, California, Forenede Stater, 91911
        • Velocity Clinical Research, Chula Vista
      • Chula Vista, California, Forenede Stater, 91910
        • GW Research
      • 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

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  1. Mand eller kvinde, alderen ≥18 år på tidspunktet for underskrivelse af informeret samtykke
  2. Ved central biopsiaflæsningsproces: diagnose af NASH i henhold til Steatosis-Activity-Fibrosis (SAF):

    1. Steatosescore ≥1
    2. Aktivitetsscore: A3 eller A4
    3. Fibrose-score: F2 eller F3
  3. Stabil dosis for lægemidlerne anført nedenfor:

    1. 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
    2. Vitamin E (hvis i en dosis ≥400 IE/dag): Stabil dosis i mindst 6 måneder
    3. Statiner: Stabil dosis i mindst 3 måneder
  4. Alle andre kronisk administrerede lægemidler skal være stabile i mindst 3 måneder før screening
  5. Vægtstabil i 6 måneder før screening og mellem den kvalificerende leverbiopsi og baseline (ikke mere end 5 % ændring for begge perioder)
  6. 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:

  1. Dokumenterede årsager til kronisk leversygdom bortset fra NASH
  2. Histologisk dokumenteret levercirrhose (fibrosestadie F4)
  3. Anamnese eller nuværende diagnose af hepatocellulært karcinom HCC
  4. Historie om eller planlagt levertransplantation
  5. Serologi af positiv human immundefektvirus (HIV).
  6. ALT eller AST >5 × ULN
  7. Unormal syntetisk leverfunktion som defineret ved screening centrallaboratorieevaluering
  8. Hæmoglobin <110 g/L (11 g/dL) for kvinder og <120 g/L (12 g/dL) for mænd
  9. Patient, der i øjeblikket modtager enhver godkendt behandling for NASH eller fedme
  10. Aktuel eller nyere historie (<5 år) med betydeligt alkoholforbrug
  11. 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:

  12. HbA1c >9 % ved screening
  13. Anden diabetes mellitus end type 2
  14. Nuværende behandling med insulin
  15. Tidligere eller nuværende behandling med PPAR-gamma-agonister (thiazolidindioner [TZD'er])

    Fedme relateret:

  16. 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:

  17. Anamnese med hjertesvigt med reduceret venstre ventrikulær ejektionsfraktion (LVEF)
  18. Atrieflimren kræver antikoagulering
  19. Ustabilt hjertesvigt
  20. Ukontrolleret hypertension ved screening (værdier >160/100 mm Hg)

    Generel sikkerhed:

  21. Kvinder, der i øjeblikket ammer
  22. Tidligere eksponering for lanifibranor
  23. 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
  24. Samtidig behandling med PPAR-alfa-agonister (fibrater)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

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:
  • Lanifibranor
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:
  • Lanifibranor
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:

  • Ved at bruge DBPC-behandlingsperioden, sammenligne de 2 aktive arme versus placebo
  • Brug af DBPC +ATE på behandlingsperioder, vurdering af de 2 aktive arme. For uønskede hændelser, bedømte leverhændelser og DILI- og MACE-hændelser, ud over de rå kumulative incidensandele, vil de eksponeringsjusterede incidensrater blive angivet baseret på den tid, patienter er i risikozonen.
48 uger efter afslutning af DBPC-periode

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

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

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. august 2021

Primær færdiggørelse (Anslået)

30. september 2027

Studieafslutning (Anslået)

30. september 2027

Datoer for studieregistrering

Først indsendt

16. april 2021

Først indsendt, der opfyldte QC-kriterier

16. april 2021

Først opslået (Faktiske)

19. april 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. maj 2026

Sidst verificeret

1. marts 2026

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med NASH - Ikke-alkoholisk Steatohepatitis

Kliniske forsøg med IVA337

Abonner