Clincosm LogoSign in Get a demo

NATiV3: A Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients With (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis

Sponsor
Inventiva Pharma (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04849728
Collaborator
(none)
2,000
Enrollment
255
Locations
3
Arms
84.4
Anticipated Duration (Months)
7.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Primary objectives

This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis stage 2 or 3 and consists of 2 parts - Part 1 and Part 2, with the following primary objectives:

Part 1 To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis assessed by liver histology.

Part 2 To assess the effect of lanifibranor compared to placebo on delaying NASH disease progression measured by a composite endpoint that includes progression to cirrhosis, liver-related clinical outcome events, or all-cause death.

Secondary objectives

Key secondary objectives of Part 1:

  • To assess the effect of lanifibranor compared to placebo on NASH resolution and no worsening of fibrosis

  • To assess the effect of lanifibranor compared to placebo on improvement of fibrosis with no worsening of NASH

Other secondary objectives of both Part 1 and Part 2:

  • To assess the effect of lanifibranor compared to placebo on other key histological features of NASH

  • To assess the effect of lanifibranor compared to placebo on NASH resolution and improvement of fibrosis in diabetic patients

  • To assess the effect of lanifibranor compared to placebo on liver function tests

  • To assess the effect of lanifibranor compared to placebo on glycaemic parameters

  • To assess the effect of lanifibranor compared to placebo on lipid parameters

  • To assess the effect of lanifibranor compared to placebo on liver stiffness

  • To assess the effect of lanifibranor compared to placebo on health-related quality of life

  • To assess the long-term safety (up to 7 years) of lanifibranor

  • To assess population PK modeling of lanifibranor using sparse sampling scheme

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomised, Double-blind, Placebo-controlled, Multicentre, Phase 3 Study Evaluating Long-term Efficacy and Safety of Lanifibranor in Adult Patients With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) and Fibrosis 2 (F2)/Fibrosis 3 (F3) Stage of Liver Fibrosis
Actual Study Start Date :
Aug 19, 2021
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Sep 1, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lanifibranor (IVA 337) (800 mg/day)

2 Lanifibranor tablets 400mg + 1 Placebo to match tablet with food --> once a day (quaque die, QD)

Drug: IVA337
A total of 2000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part 1 and Part 2.
Other Names:
  • Lanifibranor

    • Drug: Placebo
    A total of 2000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part 1 and Part 2.
    Experimental: Lanifibranor (IVA 337) (1200 mg/day)

    3 Lanifibranor tablets 400mg with food --> once a day (quaque die, QD)

    Drug: IVA337
    A total of 2000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part 1 and Part 2.
    Other Names:
  • Lanifibranor

    		•
    Placebo Comparator: Matching placebo

    3 Placebo to match tablets with food --> once a day (quaque die, QD)

    Drug: Placebo
    A total of 2000 patients will be randomised to receive lanifibranor (800 mg/day) or lanifibranor (1200 mg/day), or matching placebo, employing a 1:1:1 randomisation scheme, respectively, without interruption between Part 1 and Part 2.

    Outcome Measures

    Primary Outcome Measures

    1. Resolution of NASH and improvement of fibrosis [Part 1: Date of randomisation until the date of biopsy at Week 72]

      Part 1: Resolution of NASH and improvement of fibrosis at Week 72, defined by NASH CRN scores for ballooning of 0 and inflammation of 0 to 1, and fibrosis score ≥1 stage decrease compared to Baseline

    2. Time to first clinical outcome event [Part 2: Date of randomisation until the End of Study (EoS) date approximately 7 years after first patient randomized]

      Part 2: Histological progression to cirrhosis (defined as histological confirmation of fibrosis score CRN F4) All-cause mortality Liver transplant Model for End-Stage Liver Disease (MELD) score ≥15 New onset ascites requiring treatment Overnight hospitalisation due to hepatic decompensation event(s) including: Hepatic encephalopathy Grade ≥2 (as assessed by West Haven scale) Variceal bleeding Spontaneous bacterial peritonitis (assessed by positive culture or cell count)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Male or female, aged ≥18 years at the time of signing informed consent

    2. Upon central biopsy reading process: diagnosis of NASH according to the

    Steatosis-Activity-Fibrosis (SAF):

    1. Steatosis score ≥1

    2. Activity score: A3 or A4

    3. Fibrosis score: F2 or F3

    4. Stable dose for the drugs listed below:

    5. Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): Stable dose for at least 3 months

    6. Vitamin E (if at a dose ≥400 IU/day): Stable dose for at least 6 months

    7. Statins: Stable dose for at least 3 months

    8. All other chronically administered drugs must be stable for at least 3 months prior to Screening

    9. Weight stable for 6 months prior to Screening and between the qualifying liver biopsy and Baseline (no more than 5% change for both periods)

    10. Negative serum pregnancy test at study Screening for females of childbearing potential confirmed by central laboratory. Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 1 month after treatment discontinuation.

    Exclusion Criteria:
    Liver-related:

    1. Documented causes of chronic liver disease other than NASH

    2. Histologically documented liver cirrhosis (fibrosis stage F4)

    3. History or current diagnosis of hepatocellular carcinoma HCC

    4. History of or planned liver transplant

    5. Positive human immunodeficiency virus (HIV) serology

    6. ALT or AST >5 × ULN

    7. Abnormal synthetic liver function as defined by Screening central laboratory evaluation

    8. Haemoglobin <110 g/L (11 g/dL) for females and <120 g/L (12 g/dL) for males

    9. Patient currently receiving any approved treatment for NASH or obesity

    10. Current or recent history (<5 years) of significant alcohol consumption

    11. Treatment with drugs that may cause non-alcoholic fatty liver disease (NAFLD) administered for at least 2 weeks within 12 months prior to qualifying liver biopsy

    Glycaemia related:

    1. HbA1c >9% at Screening

    2. Diabetes mellitus other than type 2

    3. Current treatment with insulin

    4. Previous or current treatment with PPAR-gamma agonists (thiazolidinediones [TZDs])

    Obesity related:
    1. Bariatric surgery: Restrictive procedures are allowed, if performed >6 months prior to the qualifying liver biopsy; malabsorptive procedures and procedures combining both restrictive and malabsorptive methods are not allowed within 5 years of the qualifying liver biopsy.
    Cardiovascular related:

    1. History of heart failure with reduced left ventricular ejection fraction (LVEF)

    2. Atrial fibrillation requiring anticoagulation

    3. Unstable heart failure

    4. Uncontrolled hypertension at Screening (values >160/100 mm Hg)

    General safety:

    1. Women currently breastfeeding

    2. Previous exposure to lanifibranor

    3. Participation in any clinical trial investigational medicinal product/device within 3 months from Screening or 5 half-lives from Screening, whichever is longer

    4. Concomitant treatment with PPAR-alpha agonists (fibrates)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Pinnacle Research Group Anniston Alabama United States 36207
    2 Digestive Health Specialist of the Southeast Dothan Alabama United States 36305
    3 North Alabama GI Research Center llc Madison Alabama United States 60602
    4 The Institute For Liver Health - Chandler Chandler Arizona United States 85224-5688
    5 Arizona Liver Health - Peoria Peoria Arizona United States 85381
    6 Adobe Gastroenterology Tucson Arizona United States 85712
    7 Arizona Liver Health Tucson Arizona United States 85712
    8 Arkansas Diagnostic Center Little Rock Arkansas United States 72205
    9 Arkansas Gastroenterology North Little Rock Arkansas United States 72117
    10 Fomatmedicalresearch Camarillo California United States 93011
    11 Precision Research Institute Chula Vista California United States 91909
    12 GW Research Chula Vista California United States 91910
    13 TriWest Research Associates El Cajon California United States 92020
    14 SC Clinical Research Garden Grove California United States 92844
    15 National Research Institute - Huntington Park Huntington Park California United States 90255
    16 National Research Institute - Westlake Los Angeles California United States 90057
    17 National Research Institute - Panorama City Panorama City California United States 91402
    18 Prospective Research Innovations Inc. Rancho Cucamonga California United States 91730
    19 Research and Education, Inc. San Diego California United States 92111
    20 California Pacific Medical Center Research Institute San Francisco California United States 64107
    21 Quest Clinical Research San Francisco California United States 94115
    22 San Fernando Valley Health Institute Van Nuys California United States 91405
    23 Bridgeport Hospital Bridgeport Connecticut United States 06610
    24 Yale School of Medicine New Haven Connecticut United States 06520
    25 Excel Medical Clinical Trials, LLC Boca Raton Florida United States 33434
    26 Synergy Healthcare Bradenton Florida United States 34208
    27 Tampa Bay Medical Research Clearwater Florida United States 33761
    28 Gastro Florida Clearwater Florida United States 33762
    29 American Research Institute, INC Cutler Bay Florida United States 33157
    30 JY Research Institute Inc. Cutler Bay Florida United States 33189
    31 Top Medical Research Cutler Bay Florida United States 33189
    32 Doral Medical Research, LLC Hialeah Florida United States 33016
    33 Palmetto Research Hialeah Florida United States 33016
    34 Florida Research Institute Lakewood Ranch Florida United States 34211
    35 Accel Research Sites Maitland Florida United States 32751
    36 Centor for Advanced Gastroenterology - Main Office - Maitland Maitland Florida United States 32751
    37 Florida Vascular Research Miami Florida United States 33012
    38 Optimus U Corporation Miami Florida United States 33125
    39 Schiff Center for Liver Diseases Miami Florida United States 33136
    40 USPA Advance Concept Medical Research Group Miami Florida United States 33157
    41 Genoma Research Group Miami Florida United States 33165
    42 Pro Live Medical Research Miami Florida United States 33175
    43 Miami Dade Medical Research Institute Miami Florida United States 33176
    44 Clinical Trials Services Corporation Miami Florida United States 33181
    45 Advanced Research Institute New Port Richey Florida United States 34653
    46 Sensible Healthcare Clinical Research Ocoee Florida United States 34761
    47 AdventHealth Transplant Institute Orlando Florida United States 32804
    48 American Research Centers of Florida Pembroke Pines Florida United States 33027
    49 Covenant Metabolic Specialists LLC - Sarasota Sarasota Florida United States 34420
    50 Athens Gastroenterology Association Athens Georgia United States 30607
    51 Digestive Healthcare of Georgia Atlanta Georgia United States 30309
    52 Research and Education Foundation of Atlanta Medical Center Atlanta Georgia United States 30312
    53 IACT Health Columbus Georgia United States 31904
    54 Southeast Clinical Research Center Dalton Georgia United States 30720
    55 Grand Teton Research Group, PLLC Idaho Falls Idaho United States 83404
    56 NorthShore University HealthSystem Skokie Illinois United States 60077
    57 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    58 Arizona Digestive Health - Sun City Kansas City Kansas United States 66160
    59 University of Kansas Medical Center Research Institute Kansas City Kansas United States 66160
    60 Kansas Medical Clinic - Gastroenterology Topeka Kansas United States 66606
    61 University of Kentucky Lexington Kentucky United States 40506-0032
    62 Gastroenterology Associates - Baton Rouge Baton Rouge Louisiana United States 70809
    63 Tandem Clinical Research Marrero Louisiana United States 70072
    64 Metropolitan Gastroenterology Associates - Metairie Metairie Louisiana United States 70006
    65 Louisiana Research Center LLC Shreveport Louisiana United States 71103
    66 Investigative Clinical Research - Annapolis Annapolis Maryland United States 21401
    67 Mercy Medical Center - Mcauley Plaza Baltimore Maryland United States 21202
    68 Digestive Disease Associates - Catonsville Catonsville Maryland United States 21228
    69 Chevy Chase Clinical Research Chevy Chase Maryland United States 20815
    70 Gastro Center of Maryland - Columbia Columbia Maryland United States 21045
    71 Meritus Center for Clinical Research Hagerstown Maryland United States 21742
    72 Beth Israel Deaconess Medical Center - Liver Center Boston Massachusetts United States 02215
    73 NECCR Prima Care Research, LLC Fall River Massachusetts United States 02721
    74 Clinical Research Institute of Michigan Chesterfield Michigan United States 48047
    75 Henry Ford Health System Detroit Michigan United States 48202
    76 MNGI Digestive Health - Northeast Minneapolis Clinic Minneapolis Minnesota United States 55413
    77 Mayo Clinic - Rochester Rochester Minnesota United States 55905
    78 Gastrointestinal Associates & Endoscopy Center - Flowood Flowood Mississippi United States 39232
    79 SKYCRNG - Quinn Healthcare Ridgeland Mississippi United States 39157
    80 SSM Health Saint Louis University Hospital Saint Louis Missouri United States 63104
    81 Washington University School of Medicine in St. Louis Saint Louis Missouri United States 63110
    82 State University of New York - University at Buffalo Buffalo New York United States 14203
    83 Charlotte Gastroenterology and Hepatology - Randolph Road Office Charlotte North Carolina United States 28207
    84 ObjectiveGI - Northeast GI Research Concord North Carolina United States 28027
    85 Cumberland Research Associates Fayetteville North Carolina United States 28304
    86 Carolina Digestive Diseases Greenville North Carolina United States 27834
    87 Lucas Research, Inc Morehead City North Carolina United States 28557
    88 Consultants for Clinical Research - Montgomery Office Cincinnati Ohio United States 45249
    89 Aventiv Research - Columbus Columbus Ohio United States 43213
    90 North Shore Gastroenterology Westlake Ohio United States 44145
    91 INTEGRIS Baptist Medical Center Oklahoma City Oklahoma United States 73112
    92 Options Health Research Tulsa Oklahoma United States 74104
    93 University of Pittsburgh Medical Center Pittsburgh Pennsylvania United States 15261
    94 Palmetto Clinical Research Summerville South Carolina United States 29485
    95 Rapid City Medical Center Rapid City South Dakota United States 57701
    96 Texas Clinical Research Institute Arlington Texas United States 76012
    97 Accelemed Research Institute Austin Texas United States 78745
    98 Pinnacle Clinical Research - Austin Austin Texas United States 78757
    99 South Texas Research Institute - Brownsville Brownsville Texas United States 78520
    100 PanAmerican Clinical Research - US Headquarters Brownsville Texas United States 78521
    101 The Liver Institute at Methodist Dallas Dallas Texas United States 75203
    102 South Texas Research Institute - Edinburg Edinburg Texas United States 78539
    103 Care United Medical Center - Forney Forney Texas United States 75126
    104 Allure Health, Llc Friendswood Texas United States 77546
    105 Digestive Health Associates of Texas - Rockwall Garland Texas United States 75044
    106 Advanced Medical Trials Georgetown Texas United States 78628
    107 Houston Methodist Hospital Houston Texas United States 77030
    108 Liver Specialists of Texas Houston Texas United States 77030
    109 Gastroenterology Consultants - Ellington Houston Texas United States 77034
    110 Headlands - Centex Studies - Westfield Houston Texas United States 77090
    111 Pioneer Research Solutions Houston Texas United States 77099
    112 Quality Research - San Antonio San Antonio Texas United States 78209
    113 Sun Research Institute San Antonio Texas United States 78215
    114 Texas Liver Institute/American Research Corporation San Antonio Texas United States 78215
    115 Pinnacle Clinical Research - San Antonio San Antonio Texas United States 78229
    116 Sherman Clinical Research Sherman Texas United States 75092
    117 Impact Research Institute Waco Texas United States 76710
    118 Tranquil Clinical Research Webster Texas United States 77598
    119 Digestive Health Research of North Texas Wichita Falls Texas United States 76301
    120 Lone Peak Family Health Draper Utah United States 84020
    121 University of Utah School of Medicine Salt Lake City Utah United States 84132
    122 University of Virginia Health System Charlottesville Virginia United States 22903
    123 Gastroenterology Associates of Northern Virginia Fairfax Virginia United States 22031
    124 Inova Medical Group - Fairfax Hospital Falls Church Virginia United States 22042
    125 Emeritas Research Group Leesburg Virginia United States 20176
    126 Bon Secours Liver Institute of Hampton Roads Newport News Virginia United States 23602
    127 Digestive & Liver Disease Specialists Norfolk Virginia United States 23502
    128 Virginia Commonwealth University Richmond Virginia United States 23284
    129 Campbelltown Hospital Liverpool New South Wales Australia 2170
    130 Liverpool Hospital Liverpool New South Wales Australia 2170
    131 John Hunter Hospital New Lambton New South Wales Australia 2305
    132 Gallipoli Medical Research Foundation Greenslopes Queensland Australia 4120
    133 Monash Medical Centre Clayton Victoria Australia 3168
    134 Austin Health Heidelberg Victoria Australia 3084
    135 Universitair Ziekenhuis Antwerpen Edegem Antwerpen Belgium 2650
    136 Hôpital Erasme Bruxelles Bruxelles Capitale Belgium 1070
    137 Ziekenhuis Oost-Limburg - Campus Sint-Jan Genk Limburg Belgium 3600
    138 Algemeen Ziekenhuis Maria Middelares Gent Oost-Vlaaderen Belgium 9000
    139 Algemeen Ziekenhuis Sint-Jan Brugge-Oostende - Campus Sint-Jan Brugge West-Vlaanderen Belgium 8000
    140 Cliniques Universitaires Saint-Luc Brussel Belgium 1200
    141 Hospital Ernesto Dornelles Porto Alegre Rio De Janeiro Brazil 90160-093
    142 Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande Do Sul Brazil 90035-903
    143 Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Cerqueira César Sao Paulo Brazil 05403-000
    144 Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Ribeirão Preto São Paulo Brazil 14051-140
    145 Fundação Faculdade Regional de Medicina de São José do Rio Preto São José Do Rio Preto São Paulo Brazil 15090-000
    146 University Multiprofile Hospital for Active Treatment St. Ivan Rilski Sofia Sofia City Bulgaria 1431
    147 University Multiprofile Hospital for Active Treatment and Emergency Medicine N.I. Pirogov Sofia Sofia City Bulgaria 1612
    148 Acibadem City Clinic Tokuda Hospital Sofia Bulgaria 1407
    149 Diagnostic Consultative Center Aleksandrovska Sofia Bulgaria 1431
    150 Diagnostic Consulting Center 20 - Sofia Еооd Sofia Bulgaria 1618
    151 Nov Rehabilitatsionen Tsentar EOOD Stara Zagora Bulgaria 6000
    152 Medical Center Medica Plus Veliko Tarnovo Bulgaria 5006
    153 Heritage Medical Research Centre Calgary Alberta Canada T2N 4Z6
    154 William Osler Health System - Brampton Civic Hospital Brampton Ontario Canada L6R 3J7
    155 Centro De Investigaciones Clínicas Viña Del Mar Viña Del Mar Valparaíso Chile 2540364
    156 Research Site s.r.o. Plzen Czechia 301 00
    157 Synexus Czech - DRS Prague Praha Czechia 120 00
    158 Hôpital Hautepierre Strasbourg Bas-Rhin France 67200
    159 Hôpital Saint-Joseph Marseille Bouches-du-Rhône France 13008
    160 CHRU de Besançon - Hôpital Jean-Minjoz Besançon Franche-Comté France 25030
    161 CHU de Lille - Hôpital Claude Huriez Lille Hauts-de-France France 59037
    162 Hôpitaux Universitaires Paris Nord Val-de-Seine - Hôpital Beaujon Clichy Ile-de-France France 92118
    163 Hôpitaux Universitaires Henri Mondor Créteil Ile-de-France France 94000
    164 Hôpital Universitaire Pitié Salpêtrière Paris Ile-de-France France 75013
    165 Hôpital Saint-Antoine Paris Ile-de-France France 75571
    166 Hôpitaux Universitaires Paris-Sud - Hôpital Paul Brousse Villejuif Ile-de-France France 94804
    167 Centre Hospitalier Universitaire de Rennes Rennes Ille-et-Vilaine France 35033
    168 Centre Hospitalier Universitaire Grenoble Alpes Grenoble Isère France 38043
    169 CHU de Limoges Limoges Limousin France 87042
    170 Centre Hospitalier Universitaire De Nantes - Hôpital Nord Laennec Nantes Loire Atlantique France 44903
    171 Hôpitaux de Brabois Vandœuvre-lès-Nancy Lorraine France 54511
    172 Centre Hosptitalier Universitaire d'Angers Angers Maine-et-Loire France 49933
    173 Hôpital Haut-Lévêque Pessac Nouvelle-Aquitaine France 33604
    174 CHU Saint-Eloi Montpellier Occitanie France 34295
    175 Hôpital Rangueil Toulouse Occitanie France 31059
    176 Clinique Pasteur Toulouse Occitanie France 31076
    177 Hôpital l'Archet Nice Provence-Alpes-Côte d'Azur France 06200
    178 Centre Hospitalier Universitaire Estaing Clermont-Ferrand Puy-de-Dôme France 63003
    179 Hôpital de la Croix Rousse Lyon Rhône-Alpes France 69317
    180 Hôpital Cochin Paris France 75014
    181 Klinische Forschung Karlsruhe GmbH Karlsruhe Baden-Württemberg Germany 76137
    182 St. Josefs-Hospital Wiesbaden Wiesbaden Hessen Germany 65189
    183 Gastroenterologische Gemeinschaftspraxis Herne Herne Nordrhein-Westfalen Germany 44623
    184 Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz Rheinland-Pfalz Germany 55131
    185 Klinikum Chemnitz Chemnitz Sachsen Germany 09116
    186 Universitätsklinikum Carl Gustav Carus Dresden Dresden Sachsen Germany 01307
    187 Eugastro Leipzig Sachsen Germany 04103
    188 EPIMED Berlin Germany 10787
    189 Gastroenterologie am Bayerischen Platz Berlin Germany 10825
    190 SYNEXUS Magyarország Egészségügyi Szolgáltató KFT Budapest Central Hungary Hungary 1036
    191 Synexus Magyarország Egészségügyi Szolgáltató Kft. - Debrecen Debrecen Hajdu-Bihar County Hungary 4025
    192 Debreceni Egyetem Klinikai Központ Kenézy Gyula Campus Debrecen Hajdú-Bihar Hungary 4031
    193 Dél-pesti Centrumkórház - Országos Hematológiai és Infektológiai Intézet Budapest Hungary 1097
    194 Shaare Zedek Medical Center Jerusalem Jerusalem District Israel 9103102
    195 Hadassah University Hospital Ein Kerem Jerusalem Jerusalem District Israel 9112001
    196 Western Galilee Hospital-Nahariya Nahariya Northern District Israel 22100
    197 Soroka Medical Center Be'er Sheva Southern District Israel 84101
    198 The Chaim Sheba Medical Center Ramat Gan Tel Aviv Israel 52621
    199 Rambam Health Care Campus Haifa Israel 3109601
    200 Centro de Investigación y Gastroenterología Cuauhtémoc Ciudad De México Mexico 06700
    201 Investigaciones Medicas Cisneros Monterrey Nuevo León Mexico 64000
    202 Radboud Universitair Medisch Centrum Nijmegen Gelderland Netherlands 6525
    203 Elisabeth-TweeSteden Ziekenhuis Tilburg North Brabant Netherlands 5000 LC
    204 Ziekenhuis Bernhoven Uden North Brabent Netherlands 5400
    205 Erasmus Medisch Centrum Rotterdam Zuid-Holland Netherlands 3015 GD
    206 Universitair Medisch Centrum Utrecht Utrecht Netherlands 3584 CX
    207 Synexus - Wrocław Wrocław Dolnoslaskie Poland 50-381
    208 Niepubliczny Zaklad Opieki Zdrowotnej Centrum Badan Klinicznych Wrocław Dolnoslaskie Poland 51-162
    209 Synexus - Warszawa Warszawa Mazowieckie Poland 01-192
    210 Synexus - Gdynia Gdynia Pomorskie Poland 81-537
    211 ID Clinic Mysłowice Silesian Voivodeship Poland 41-400
    212 Synexus - Katowice Katowice Slaskie Poland 40-040
    213 Centrum Medyczne Pratia - Katowice Katowice Slaskie Poland 40-081
    214 Synexus - Poznań Poznań Wielkopolskie Poland 60-702
    215 Synexus Polska Sp. z o.o. Oddzial w Gdansku Gdańsk Poland 80-382
    216 Synexus - Łódź Łódź Łódzkie Poland 90-127
    217 Synexus - Częstochowa Czestochowa Śląskie Poland 42-202
    218 Hospital da Senhora da Oliveira - Guimarães Guimarães Braga Portugal 4835-044
    219 Hospital de Braga Braga Portugal 4710-243
    220 Centro Hospitalar Universitário Lisboa Norte - Hospital De Santa Maria Lisboa Portugal 1649-035
    221 Centro Hospitalar Universitário De São João Porto Portugal 4200-319
    222 Synexus - Mediclinic Southern Africa - Constantiaberg Cape Town Western Cape South Africa 7800
    223 Synexus - Helderberg Clinical Research Centre - Somerset West Somerset West Western Cape South Africa 7130
    224 Synexus Clinical Research SA- Watermeyer Pretoria South Africa 0184
    225 Hospital Universitario Son Espases Palma De Mallorca Balearic Islands Spain 07120
    226 Consorci Corporació Sanitària Parc Taulí de Sabadell Sabadell Barcelona Spain 08208
    227 Hospital Universitario Marqués de Valdecilla Santander Cantabria Spain 39008
    228 Hospital Clínico Universitario de Santiago Santiago de Compostela La Coruña Spain 15706
    229 Hospital Universitario Fundación Alcorcón Alcorcón Madrid Spain 28922
    230 Hospital Universitario Puerta de Hierro - Majadahonda Majadahonda Madrid Spain 28222
    231 Complejo Hospitalario Torrecárdenas Almería Spain 04009
    232 Hospital Germans Trias i Pujol Badalona Spain 08916
    233 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025
    234 Hospital Universitari Vall d'Hebrón Barcelona Spain 08035
    235 Complejo Asistencial Universitario de Leon León Spain 24080
    236 Hospital General Universitario Gregorio Marañón Madrid Spain 28007
    237 Clínica Universidad de Navarra - Madrid Madrid Spain 28027
    238 Complejo Hospitalario De Pontevedra Pontevedra Spain 36004
    239 Hospital Universitario Virgen del Rocío Sevilla Spain 41011
    240 Hospital Universitario Virgen de Valme Sevilla Spain 41014
    241 Hospital Clínico Universitario de Valencia Valencia Spain 46010
    242 Consorci Hospital General Universitari de València Valencia Spain 46014
    243 Hospital Universitario Rio Hortega Valladolid Spain 47012
    244 Hospital Clinico Universitario Lozano Blesa Zaragoza Spain 50009
    245 Hospital Universitario Miguel Servet Zaragoza Spain 50009
    246 Medical Center Edelweiss Medics, LLC Kyiv Ukraine 2002
    247 Medical Center Medbud-Clinic, LLC Kyiv Ukraine 3037
    248 Medical Center Center of Family Medicine Plus, LLC Kyiv Ukraine 4210
    249 Barts Health NHS Trust London England United Kingdom E1 1BB
    250 Panthera Biopartners - North London London England United Kingdom EN1 1LJ
    251 King's College Hospital NHS Foundation Trust London England United Kingdom SE5 9RS
    252 Panthera Biopartners - Manchester Manchester England United Kingdom OL11 4AU
    253 Panthera Biopartners - Preston Preston England United Kingdom PR2 9QB
    254 Royal Surrey County Hospital NHS Foundation Trust Surrey Quays England United Kingdom GU2 7XX
    255 Panthera Biopartners - Glasgow Glasgow North Lanarkshire United Kingdom G51 4TF

    Sponsors and Collaborators

    • Inventiva Pharma

    Investigators

    • Principal Investigator: Arun J Sanyal, MD, VCU Health, Gastroenterology Hepatology and Nutrition, 1200 West Broad Street, Richmond VA23298, USA
    • Principal Investigator: Sven Francque, MD, Division of Gastroenterology and Hepatology, Antwerp University Hospital, Wilrijkstraat 10, B-2650 Edegem, Belgium

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Inventiva Pharma
    ClinicalTrials.gov Identifier:
    NCT04849728
    Other Study ID Numbers:
    • 337HNAS20011
    First Posted:
    Apr 19, 2021
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Inventiva Pharma
    Phase III
    Nonalcoholic Steatohepatitis
    NASH
    Peroxisome proliferator-activated receptor (PPAR)
    Liver Diseases
    Fibrosis
    Additional relevant MeSH terms:
    Fatty Liver
    Non-alcoholic Fatty Liver Disease
    Liver Cirrhosis
    Fibrosis

    Study Results

    No Results Posted as of Aug 3, 2022