Clinical trial NCT06016842: A Long-Term Study of Elafibranor in Adult Participants With Primary Biliary Cholangitis
Official title: A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Primary Biliary Cholangitis (PBC)
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2023-08-30
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) and cirrhosis (scarring of the liver).

PBC is a slowly progressive disease, characterised by damage to the bile ducts in the liver, leading to a build-up of bile acids which causes further damage.

The liver damage in PBC may lead to cirrhosis. PBC may also be associated with multiple symptoms. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.

This study will compare a daily dose of elafibranor (the study drug) to a daily dose of placebo (a dummy treatment) and will last up to 3.5 years for each participant.

The main aim of this study is to determine if elafibranor is better than placebo in preventing clinical outcome events showing disease worsening (including progression of disease leading to liver transplant or death).

This study will also study the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itching and tiredness.


Eligibility criteria: Inclusion Criteria :

* Male or female participants must be ≥18 years of age at the time of signing the informed consent.
* Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC)
* Participants with cirrhosis at SV1. • Participants must be Child Pugh A or Child Pugh B.
* Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion Criteria :

* History or presence of other concomitant liver disease including but not limited to:

  * i) Primary sclerosing cholangitis (PSC).
  * ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) ≥6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA.
  * iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative.
  * iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be enrolled if a confirmatory HCV RNA is undetectable and sustained viral response has been documented).
  * v) Alcohol-associated liver disease (ALD).
  * vi) Nonalcoholic steatohepatitis (NASH).
  * vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency.
* History or presence of clinically significant hepatic decompensation, including:

  * i) History of liver transplantation, current placement on a liver transplant list, current model for end-stage liver disease including (MELD) 3.0 score \>12 due to hepatic impairment.
  * ii) Evidence of complications of cirrhosis, including hepatic decompensation or evidence of significant portal hypertension complications including presence of uncontrolled ascites; history of variceal bleeding or related interventions (e.g. variceal banding, or transjugular intrahepatic portosystemic shunt placement); presence of hepatic encephalopathy Grade 2 or higher per West-Haven criteria; history or presence of spontaneous bacterial peritonitis. Note: participants with low-risk varices (Grade I) without history of bleeding or other treatment may be eligible to enrol.
  * iii) Hepatorenal syndrome (HRS) (type I or II ). • vi) Hospitalisation for liver-related complication within 12 weeks prior to SV1.
* Known history of human immunodeficiency virus (HIV) infection or having a positive confirmatory test for HIV type 1 or 2.
* Medical conditions that may cause non-hepatic increases in ALP (e.g. Paget's disease).
* Evidence of any other unstable or untreated clinically significant immunological, endocrine, hematologic, gastrointestinal, neurological, or psychiatric disease as evaluated by the investigator; other clinically significant conditions that are not well controlled.
* Non-hepatic medical conditions that may diminish life expectancy to \<2 years, including known cancers.
* History of hepatocellular carcinoma.
* Alpha-fetoprotein (AFP) \>20 ng/mL with 4-phase liver computerised tomography (CT) or magnetic resonance imaging (MRI) imaging suggesting presence of hepatocellular carcinoma.
* Known malignancy or history of malignancy within the last 5 years, with the exception of local, successfully treated basal cell carcinoma or in-situ carcinoma of the uterine cervix.
* Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: • i) 3 months prior to screening period: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including α-methyl-dopa, sodium valproic acid, isoniazid or nitrofurantoin).
* Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period.

  i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer.ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent.
* Electrocardiogram (ECG) with QT interval corrected by Fridericia's formula (QTcF) \>450 msec in males or QTcF \>470 msec in females for participants without bundle branch block. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF \>480 msec would be exclusionary.
* Total bilirubin (TB) \>5x ULN
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \>5x ULN at SV1
* Creatinine phosphokinase (CPK) \>2x ULN.
* Platelet count \<50,000/μL
* International normalised ratio (INR) \>1.8 in the absence of anticoagulant therapy.
* Estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73m2 per the Modification of Diet in Renal Disease (MDRD)-6 Study formula at SV1.
* Significant renal disease, including nephritic syndrome, chronic kidney disease (CKD) (defined as participants with evidence of significantly impaired kidney function or underlying kidney injury).
* For female participants: known current pregnancy, or has a positive serum pregnancy test, or is breastfeeding.
* Regular alcohol intake in excess of the recommended limit of 1 standard drink per day for men or women.
* History of alcohol abuse, or other substance abuse within 1 year prior to SV1.
* Known hypersensitivity to elafibranor or to any of the excipients of the investigational product(s).
* Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
* Any other condition that, in the opinion of the investigator, would interfere with study participation or completion, or would put the participant at risk, including a potential participant assessed as being at high risk of noncompliance with the study.
* Alkaline phosphatase (ALP) ≥10x ULN.
* Albumin \<2.8 g/dL due to impaired hepatic function.

Primary outcomes:
measure: Event-free survival
timeFrame: From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
Secondary outcomes:
measure: Percentage of participants experiencing Treatment Emergent Adverse Events (TEAEs), treatment-related TEAEs, Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs)
timeFrame: From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants developing clinically significant changes in physical examination findings
timeFrame: From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants developing clinically significant changes in vital signs
timeFrame: From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants developing clinically significant changes in Electrocardiogram (ECG) readings.
timeFrame: From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with clinically significant changes in laboratory parameters (blood chemistry, hematology, coagulation and urinalysis)
timeFrame: From baseline until 4 weeks after the end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in Alkaline phosphatase (ALP)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in Total Bilirubin (TB)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with ALP≤ 1.67x ULN and TB≤ ULN
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with complete biochemical response
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with normalisation of TB and ALP
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with stabilisation in TB (i.e. no increase)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with a response based on albumin normalisation
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in liver stiffness measurement (LSM)
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in PBC risk scores based in Global PBC Study Group (GLOBE) score
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in PBC risk scores based on United Kingdom (UK)-PBC score.
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with LSM ≥15 kPa
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change in serum levels of Aspartate aminotransferase (AST) compared to the baseline
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change in serum levels of ALT compared to the baseline
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change in serum levels of Gamma-glutamyl transferase (GGT) compared to the baseline
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in hepatic function: Conjugated bilirubin
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change in serum levels of Albumin compared to the baseline
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in hepatic function: international normalised ratio (INR)
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in hepatic function: fractionated ALP
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with no worsening of LSM
timeFrame: At Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with ALP reduction of 40%
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with ALP <1.5x ULN, ALP decrease ≥15% and TB ≤ULN
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with ALP <1.5x ULN, ALP decrease ≥40% and TB ≤ULN
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with ALP <1.67x ULN, ALP decrease ≥15% and TB ≤ULN
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with ALP <3x ULN, AST <2x ULN and TB ≤1 mg/dL (Paris I)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with ALP ≤1.5x ULN, AST ≤1.5x ULN and TB ≤1 mg/dL (Paris II criteria)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with normalisation of abnormal TB
timeFrame: Assessed at Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with normalisation of abnormal TB and albumin (Rotterdam criteria)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with reduction in TB to ≤0.6x ULN in participants with TB >0.6x ULN at baseline
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in lipid parameters: total cholesterol (TC)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in lipid parameters: high density lipoprotein cholesterol (HDL-C)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in lipid parameters: calculated very low density lipoprotein cholesterol (VLDL-C)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in lipid parameters: low density lipoprotein cholesterol (LDL-C)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in lipid parameters: triglycerides (TG)
timeFrame: At Month 6, Month 12, and every 12 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with a response in PBC Worst Itch NRS score
timeFrame: Through 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Percentage of participants with a response in PBC Worst Itch NRS
timeFrame: Assessed through 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in 5D-Itch scale
timeFrame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in Patient Global Impression of Severity (PGI-S)
timeFrame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Patient Global Impression of Change (PGI-C)
timeFrame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in Patient Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form 7a
timeFrame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in the Epworth Sleepiness Scale (ESS)
timeFrame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in PBC-40 score
timeFrame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in PBC Worst Itch Numeric Rating Scale (NRS) score
timeFrame: Assessed through 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5L)
timeFrame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in Work Productivity and Activity Impairment General Health (WPAI-GH)
timeFrame: Assessed at every 6 months up to end of treatment (maximum duration of 3.5 years)
measure: Time to the first occurrence of each of individual adjudicated clinical outcome events
timeFrame: From baseline until 4 weeks after the end of treatment
measure: Area under the plasma concentration-time curve from time 0 to 24 hours: AUC0-24
timeFrame: At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
measure: Maximum (peak) plasma drug concentration: Cmax
timeFrame: At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
measure: Time to reach maximum (peak) plasma concentration following drug administration): Tmax
timeFrame: At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
measure: Apparent clearance of drug from plasma (CL)
timeFrame: At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
measure: Apparent volume of distribution (VZ)
timeFrame: At Day 1/Baseline, Month 6 and Month 12 (during a dosing period of 24 hours)
measure: Change from baseline in model for end-stage liver disease (MELD) 3.0 score
timeFrame: From screening until end of treatment (maximum duration of 3.5 years)
measure: Change from baseline in Child Pugh grade
timeFrame: From screening until end of treatment (maximum duration of 3.5 years)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Liver Health
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Diagnostic Center, PA
state: Arkansas
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: GastroIntestinal BioSciences
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology, P.C.
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Gastroenterology
state: Colorado
city: Miami
country: United States
facility: University Of Miami School Of Medicine, Center For Liver Diseases
state: Florida
city: Tampa
country: United States
facility: International Center for Research
state: Florida
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates - Center for Digestive Care
state: Michigan
city: Albuquerque
country: United States
facility: Southwest Gastroenterology Associates, PC (SWGA)
state: New Mexico
city: New York
country: United States
facility: NYU Langone Gastroenterology and Hepatology Associates
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Cordova
country: United States
facility: Gastroenterology Center of the Midsouth
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Austin
country: United States
facility: American Research Corporation
state: Texas
city: Dallas
country: United States
facility: Rush University Medical Center - University Cardiovascular Surgeons
state: Texas
city: Dallas
country: United States
facility: Liver Center of Texas
state: Texas
city: Dallas
country: United States
facility: Methodist Transplant Physicians
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Fort Worth
country: United States
facility: Baylor Scott & White All Saints Medical Center - Forth Worth
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas
state: Texas
city: Houston
country: United States
facility: Houston Methodist Cancer Center
state: Texas
city: Katy
country: United States
facility: Gastro health & Nutrition
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation at The Texas Liver Institute
state: Texas
city: Waco
country: United States
facility: Impact Research Tx
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond, Inc
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center - West Hospital
state: Virginia
city: Columbia
country: United States
facility: Medstar Georgetown Transplant Institute University Hospital (MGUH)
state: Washington
city: Seattle
country: United States
facility: Velocity Clinical Research at Liver Institute Northwest
state: Washington
city: Buenos Aires
country: Argentina
facility: Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L
city: Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Córdoba
country: Argentina
facility: Centro Medico Colon
city: Mendoza
country: Argentina
facility: Hospital Espanol de Mendoza
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
city: Birtinya
country: Australia
facility: Sunshine Coast University Hospital
city: Footscray
country: Australia
facility: Footscray Hospital, Western Health
city: Kingswood
country: Australia
facility: Nepean Clinical School
city: Melbourne
country: Australia
facility: Monash University - Monash Health -Monash Medical Centre
city: Sydney
country: Australia
facility: St George Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: Edegem
country: Belgium
facility: Universitair Ziekenhuis Antwerpen
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: Gent University Hospital
city: Roeselare
country: Belgium
facility: Algemeen Ziekenhuis Delta
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre (HCPA)
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
city: São Paulo
country: Brazil
facility: Hospital de Base - Centro Integrado de Pesquisa ( CIP )
city: São Paulo
country: Brazil
facility: Universidade Estadual Paulista Julio De Mesquita Filho (UNESP) Hospital das Clinicas Faculdade de Medicina de Botucatu (HCFMB)
city: Edmonton
country: Canada
facility: University of Alberta - Faculty of Medicine & Dentistry - The Centre of Excellence for Gastrointestinal Inflammation and Immunity Research (CEGIIR)
city: Toronto
country: Canada
facility: University Health Network (UHN) - Toronto General Hospital (TGH) - Toronto General Research Institute (TGRI)
city: Las Condes
country: Chile
facility: Universidad De Los Andes
city: Santiago
country: Chile
facility: Enroll SpA
city: Santiago
country: Chile
facility: University of Chile Clinical Hospital (Hospital Clinico de la Universidad de Chile)
city: Viña Del Mar
country: Chile
facility: Centro Medico Cedid - Centro de Diagnostico Digestivo
city: Hradec Králové
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Liberec
country: Czechia
facility: Krajska Nemocnice Liberec
city: Ostrava
country: Czechia
facility: Artroscan
city: Plzen
country: Czechia
facility: Research Site s.r.o.
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine - IKEM
city: Copenhagen
country: Denmark
facility: Bispebjerg Hospital
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille - Hopital Claude Huriez
city: Lyon
country: France
facility: Hospices Civils de Lyon (HCL) - Hopital de la Croix-Rousse
city: Marseille
country: France
facility: Hopital Saint Joseph - Marseille
city: Nice
country: France
facility: CHU de Nice, Hopital de l'Archet
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Universitaire Pitie Salpetriere (Hopital Pitie-Salpetriere)
city: Poitiers
country: France
facility: CHU Poitiers
city: Toulouse
country: France
facility: Clinique Pasteur
city: Villejuif
country: France
facility: Hopital Paul-Brousse - APHP
city: Modena
country: Italy
facility: Azienda Ospedaliero Universitaria Modena
city: Monza
country: Italy
facility: Ospedale San Gerardo
city: Naples
country: Italy
facility: Azienda Ospedaliero Universitaria Federico II di Napoli
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova - U.O.C. di Gastroenterologia
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
city: Pavia
country: Italy
facility: Fondazione I.R.C.C.S. Policlinico San Matteo
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: San Giovanni Rotondo
country: Italy
facility: Ospedale Casa Sollievo della Sofferenza
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital (PNUH)
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea Daejeon St.Mary's Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Junggu
country: Korea, Republic of
facility: Kyungpook National University Hospital (KNUH)
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital (SNUBH)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Eunpyeong St. Mary's Hospital
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic University of Korea, Uijeongbu St. Mary's Hospital
city: Ciudad de mexico
country: Mexico
facility: Centro de Investigacion y Gastroenterologia SC
city: Jalisco
country: Mexico
facility: Centro de Investigacion Medico Biologica y Terapia Avanzada
city: Yucatán
country: Mexico
facility: Medical Care & Research
city: Christchurch
country: New Zealand
facility: Canterbury District Health Board
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Elbląg
country: Poland
facility: NZOZ Twoje Zdrowie EL Sp. z o.o.
city: Katowice
country: Poland
facility: Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne Sp.z.o.o - FutureMeds
city: Kraków
country: Poland
facility: Szpital Uniwersytecki w Krakowie
city: Małogoskie
country: Poland
facility: Krakowskie Centrum Medyczne Sp.z.o.o. - FutureMeds
city: Sosnowiec
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poliklinika Doktora Bessera
city: Warszawa
country: Poland
facility: FutureMeds Warszawa Centrum
city: Wrocław
country: Poland
facility: FutureMeds sp. z o. o
city: Bucharest
country: Romania
facility: Centrul Pentru Studiul Metabolismului
city: Bucharest
country: Romania
facility: Sana S.R.L
city: Bucharest
country: Romania
facility: Spital Clinic Dr I Cantacuzino
city: Cluj-Napoca
country: Romania
facility: Cluj County Clinical Emergency Hospital
city: Iaşi
country: Romania
facility: Gastromedica Srl
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Madrid
country: Spain
facility: Clinica Universidad Navarra-Sede Madrid
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon (HGUGM)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro de Majadahonda
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Pontevedra
country: Spain
facility: Hospital De Montecelo
city: Sabadell
country: Spain
facility: Institut d Investigacio i Innovacio Parc Tauli, Hospital Universitari Parc Tauli
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe
city: Valladolid
country: Spain
facility: Hospital Universitario Rio Hortega
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: