Clinical trial NCT04526665: Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
Official title: A Double-blind, Randomized, Placebo-Controlled Study and Open-label Long Term Extension to Evaluate the Efficacy and Safety of Elafibranor 80 mg in Patients With Primary Biliary Cholangitis With Inadequate Response or Intolerance to Ursodeoxycholic Acid
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Primary Biliary Cirrhosis
Keywords: Primary Biliary Cholangitis
PBC
Elafibranor
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2020-08-26
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a double-blind (DB), randomized, placebo-controlled study followed by an open-label long term extension (LTE)
Primary purpose: TREATMENT

Brief summary: The participants of this study will have confirmed Primary Biliary Cholangitis (PBC) with inadequate response or intolerance to ursodeoxycholic acid (which is a medication used in the management and treatment of cholestatic liver disease).

PBC is a slowly progressive disease characterized by damage of the bile ducts in the liver, leading to a buildup of bile acids which causes further damage. The liver damage in PBC may lead to scarring (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.

The main aim of this study is to determine if elafibranor (the study drug) is better than placebo (a dummy treatment) at decreasing the levels of a specific blood test (alkaline phosphatase) that provides information about participant's disease. This study will also evaluate the safety of long-term treatment with elafibranor, as well as the impact on symptoms such as itchy skin (pruritus) and tiredness (fatigue).

This study has two main parts:

Part 1 will compare a daily dose of elafibranor to a daily dose of placebo and will last between a minimum of one year and a maximum of two years.

Part 2, all participants will receive elafibranor for a period of up to 5 years or until the total treatment duration (part 1 and part 2) reaches 6 years, whichever occurs first.


Eligibility criteria: Inclusion Criteria

* Males or females age of 18 to 75 years (inclusive)
* Definite or probable Primary biliary cholangitis (PBC) diagnosis
* Alkaline phosphatase (ALP) ≥ 1.67x upper limit of normal (ULN)
* Total bilirubin (TB) ≤ 2x ULN
* Ursodeoxycholic acid (UDCA) for at least 12 months (stable dose ≥ 3 months) prior to screening, or unable to tolerate UDCA treatment (no UDCA for ≥ 3 months) prior to screening (per country standard-of-care dosing)
* Must have PBC Worst Itch Numeric rating scale (NRS) collected prior to randomization
* Females participating in this study must be of non-child bearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the last drug intake

Exclusion Criteria:

* History or presence of other concomitant liver disease
* Clinically significant hepatic decompensation, including patients with complications of cirrhosis/portal hypertension
* Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease) or which may diminish life expectancy to \< 2 years, including known cancers
* Patient has a positive test for HIV Type 1 or 2 at screening, or patient is known to have tested positive for HIV
* Evidence of any other unstable or untreated clinically significant disease
* History of alcohol abuse
* For female patients: known pregnancy or lactating
* Use of fibrates and glitazones within 2 months prior to screening
* Use of Obeticholic acid (OCA), 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) within 3 months prior to screening
* Use of antibodies or immunotherapy directed against interleukins (ILs) or other cytokines or chemokines within 12 months prior to screening
* For patients with previous exposure to OCA, OCA should be discontinued 3 months prior to screening
* Patients 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 five half-lives, whichever is longer, prior to screening; for patients with previous exposure to seladelpar, seladelpar should be discontinued 3 months prior to screening
* Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) values \> 5 x ULN
* For patients with AT or TB\>ULN at SV1, variability of AT or TB \> 40% (see section 3.5.1)
* Albumin\<3.0 g/dl
* Severely advanced patients according to Rotterdam criteria (TB \> ULN and albumin \<LLN)
* INR \> 1.3 due to altered hepatic function
* CPK \> 2 x ULN
* Screening serum creatinine \> 1.5 mg/dl
* Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney failure damage or eGFR \< 60 mL/min/1.73 m\^2) calculated by Modification of diet in renal disease (MDRD)
* Platelet count \< 150 x 10\^3/μL
* AFP \> 20 ng/mL with 4-phase liver CT or MRI imaging suggesting presence of liver cancer
* Known hypersensitivity to the investigational product or to any of the formulation excipients of the elafibranor or placebo tablet Mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain

Primary outcomes:
measure: Percentage of Participants With Response to Treatment Based on Cholestasis Response at Week 52
timeFrame: At Week 52
Secondary outcomes:
measure: Key Secondary Endpoint: Percentage of Participants With Response to Treatment Based on ALP Normalization at Week 52
timeFrame: At Week 52
measure: Key Secondary Endpoint: Change From Baseline in Pruritus Based on PBC Worst Itch Numeric Rating Scale (NRS) Score in Participants With Baseline PBC Worst Itch NRS Score ≥4 to Week 52
timeFrame: Baseline (up to 14 days pre-dose) and Week 52
measure: Key Secondary Endpoint: Change From Baseline in Pruritus Based on PBC Worst Itch NRS Score in Participants With Baseline PBC Worst Itch NRS Score ≥4 to Week 24
timeFrame: Baseline (up to 14 days pre-dose) and Week 24
measure: Change From Baseline in ALP at Weeks 4, 13, 26, 39 and 52
timeFrame: Baseline (Day 1) and at Weeks 4, 13, 26, 39 and 52
measure: Percentage of Participants With ALP Response From Baseline at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Percentage of Participants With Response to Treatment According to ALP < 1.5x ULN, ALP Decrease From Baseline >= 40% and TB =<ULN at Week 52
timeFrame: At Week 52
measure: Percentage of Participants With Response to Treatment According to ALP < 3x ULN, Aspartate Aminotransferase (AST) < 2x ULN and TB =< 1 Milligrams Per Deciliter (mg/dL) (Paris I) at Week 52
timeFrame: At Week 52
measure: Percentage of Participants With Response to Treatment According to ALP =< 1.5x ULN, AST =< 1.5x ULN and TB =< 1 mg/dL (Paris II) at Week 52
timeFrame: At Week 52
measure: Percentage of Participants With Response to Treatment According to TB Decrease of 15% Change From Baseline at Week 52
timeFrame: At Week 52
measure: Percentage of Participants With Response to Treatment According to Normalization of TB (TB =< ULN) and/or Albumin (ALB >= Lower Limit of Normal [LLN]) (Rotterdam) at Week 52
timeFrame: At Week 52
measure: Percentage of Participants With Response to Treatment According to TB ≤0.6 x ULN at Week 52
timeFrame: At Week 52
measure: Percentage of Participants With Response to Treatment According to ALP ≤1.67 x ULN and TB ≤1 mg/dL (Momah/ Lindor) at Week 52
timeFrame: At Week 52
measure: Percentage of Participants With Response to Treatment According to no Worsening of TB at Week 52
timeFrame: At Week 52
measure: Percentage of Participants With Response to Treatment According to Complete Biochemical Response at Week 52
timeFrame: At Week 52
measure: PBC 5-, 10- and 15-year Risk Scores Based on United Kingdom (UK)-PBC Score at Week 52
timeFrame: At Week 52
measure: Global PBC Study Group (GLOBE) Score at Week 52
timeFrame: At Week 52
measure: Change From Baseline in Hepatobiliary Injury and Liver Function as Assessed by AST, ALT, Gamma-glutamyl Transferase (GGT), 5 Prime Nucleotidase (5'-NT), and Fractionated ALP (Hepatic) (H1 and H2) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Hepatobiliary Injury and Liver Function as Measured by Total and Conjugated Bilirubin at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Hepatobiliary Injury and Liver Function as Measured by Albumin at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Hepatobiliary Injury and Liver Function as Measured by INR at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Biomarkers of Inflammation as Measured by High-sensitivity C-reactive Protein (hsCRP) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Biomarkers of Inflammation as Measured by Fibrinogen and Haptoglobin at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Biomarkers of Inflammation as Measured by Tumor Necrosis Factor Alpha at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Immune Response as Measured by Immunoglobulin (Ig)G and IgM at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Biomarkers and Non-invasive Measures of Hepatic Fibrosis as Measured by Enhanced Liver Fibrosis (ELF) and Plasminogen Activator Inhibitor-1 (PAI-1) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Biomarkers and Non-invasive Measures of Hepatic Fibrosis as Measured by Cytokeratin-18 (CK-18) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Biomarkers and Non-invasive Measures of Hepatic Fibrosis as Measured by Transforming Growth Factor Beta (TGF-beta) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Liver Stiffness Measured by Transient Elastography (TE) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Lipid Parameters at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Bile Acids and Biomarkers of Bile Acid Synthesis at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline at Week 52 in Bile Acids and Biomarkers of Bile Acid Synthesis as Measured by 7 Alpha-hydroxy-4-cholesten-3-one (C4) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Bile Acids and Biomarkers of Bile Acid Synthesis as Measured Fibroblast Growth Factor 19 at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Percentage of Participants With Response in PBC Worst Itch NRS Score at Weeks 24 and 52
timeFrame: Baseline (up to 14 days pre-dose) and at Week 24 and Week 52
measure: Percentage of Participants With no Worsening of Pruritus as Measured by the PBC Worst Itch NRS Score at Weeks 24 and 52
timeFrame: Baseline (up to 14 days pre-dose) and at Week 24 and Week 54
measure: Change From Baseline in 5-D Itch at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form 7a at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Epworth Sleepiness Scale (ESS) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in PBC-40 at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Health Utility as Measured by the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in T-Scores for Bone Mineral Density Assessed by Dual-energy X-ray Absorptiometry (DEXA) Scanning at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Serum Markers of Bone Turnover Carboxy Terminal Crosslinked Telopeptides of Type 1 Collagen [CTX] at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Change From Baseline in Serum Markers of Bone Turnover Type 1 Procollagen Peptide [P1NP]) at Week 52
timeFrame: Baseline (Day 1) and at Week 52
measure: Percentage of Participants With Onset of Clinical Outcomes
timeFrame: From Day 1 up to Week 52
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interest (AESIs)
timeFrame: TEAEs were collected from the start of study treatment administration (Day 1) up to DCO date of 01 June 2023, approximately 980 days.
measure: Plasma Concentrations of Elafibranor and GFT1007
timeFrame: Week 4: pre-dose, 0.5 hour, 1.5 hours, between 2-3 hours, 4 hours and 6 hours post-dose
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health
state: Arizona
city: Los Angeles
country: United States
facility: Keck Medical Center of USC
state: California
city: Los Angeles
country: United States
facility: Ruane Clinical Research Group Inc.
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis Medical Center
state: California
city: San Francisco
country: United States
facility: California Pacific Medical Center - Sutter Pacific Medical Foundation
state: California
city: Aurora
country: United States
facility: University of Colorado Denver and Hospital
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology, P.C.
state: Colorado
city: New Haven
country: United States
facility: Yale School of Medicine, Digestive Diseases
state: Connecticut
city: Jacksonville
country: United States
facility: Encore Borland-Groover Clinical Research
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases/University of Miami
state: Florida
city: Atlanta
country: United States
facility: Digestive Healthcare of Georgia
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center (BIDMC)
state: Massachusetts
city: Novi
country: United States
facility: Henry Ford Health System
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: New Hyde Park
country: United States
facility: UPMC Center for Liver Diseases
state: New York
city: New York
country: United States
facility: NYU Langone Health / NYU Grossman School of Medicine
state: New York
city: New York
country: United States
facility: Columbia University Medical Center - Center for Liver Disease and Transplantation
state: New York
city: New York
country: United States
facility: The New York-Presbyterian Hospital, David H. Koch Center
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Huntersville
country: United States
facility: Carolinas Centre for Liver disease/ Atrium Health
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Hershey
country: United States
facility: Investigational Drug Service Pharmacy Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina- College of Medicine
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Digestive Disease Center
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Dallas
country: United States
facility: Liver Center of Texas, PLLC
state: Texas
city: Dallas
country: United States
facility: The University of Texas Southwestern Medical Center-IDS Aston Pharmacy
state: Texas
city: Fort Worth
country: United States
facility: Texas Digestive Disease Consultants dba GI Alliance
state: Texas
city: Houston
country: United States
facility: Liver Associates of Texas, P.A.
state: Texas
city: Houston
country: United States
facility: St. Luke's Health-Baylor St Luke's Medical center - Advanced Liver Therapies Research
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation
state: Texas
city: Victoria
country: United States
facility: Gastro health & Nutrition-Victoria
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center - Transplant Services
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah Hospital-Division of Gastroenterology, Hepatology, and Nutrition
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Newport News
country: United States
facility: Maryview Hospital Inc, Bon Secours Liver Institute of Hampton Roads
state: Virginia
city: Richmond
country: United States
facility: Richmond Community Hospital LLC, Bon Secours Liver Institute of Richmond
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Clinical Research Services Unit (CRSU)
state: Virginia
city: Seattle
country: United States
facility: Liver Institute Northwest
state: Washington
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
state: Buenos Aires
city: Caba
country: Argentina
facility: Hospital Alemán
state: Buenos Aires
city: Caba
country: Argentina
facility: Hospital Británico de Buenos Aires
state: Buenos Aires
city: Godoy Cruz
country: Argentina
facility: Hospital Espanol De Mendoza
state: Mendoza
city: La Plata
country: Argentina
facility: Hospital Italiano de La Plata
state: Provincia De Buenos Aires
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario
state: Santa Fe
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Edegem
country: Belgium
facility: Antwerp University Hospital
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo-HCFMUSP
state: Sao Paulo
city: Calgary
country: Canada
facility: University of Calgary Liver Unit - Heritage Medical Research Clinic (HMRC)
state: Alberta
city: Vancouver
country: Canada
facility: Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology
state: British Columbia
city: Winnipeg
country: Canada
facility: Shared Health Inc.-Operating as Health Sciences Centre-John Buhler Research Centre
state: Manitoba
city: Montréal
country: Canada
facility: Centre de Recherche du Centre Hospitalier de l'Université de Montreal (CRCHUM)
city: La Serena
country: Chile
facility: Hospital de La Serena
state: Coquimbo
city: Viña Del Mar
country: Chile
facility: Centro de Investigaciones Clinicas (CIC)
state: Region De Valparaiso
city: Santiago
country: Chile
facility: Clínica Universidad de los Andes
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
city: Santiago
country: Chile
facility: Centro de Investigacion Clinica Universidad Catolica CICUC
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Créteil
country: France
facility: Hôpital Henri Mondor
city: Grenoble
country: France
facility: CHU Grenoble Alpes - Hôpital Albert Michallon
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans
city: Paris
country: France
facility: Hôpital Saint-Antoine
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital Pitié-Salpétrière
city: Pessac
country: France
facility: Hôpital Haut Lévêque
city: Reims
country: France
facility: Hôpital Robert Debré - CHU de Reims
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
city: Berlin
country: Germany
facility: Gastro - Sudien
city: Berlin
country: Germany
facility: Charite - Universitätsmedizin Berlin- CVK - Medizinische Klinik
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Center for Gastroenterology and Hepatology (GHZ) Kiel
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
city: Mainz
country: Germany
facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz
city: Modena
country: Italy
facility: Ospedale Civile di Baggiovara-Struttura Complessa di Medicina ad indririzzo Metabolico Nutrizionale
state: Località Baggiovara
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi
city: Milano
country: Italy
facility: Azienda Ospedaliera San Paolo, Dipartimento di Scienza della Salute, UO Medicina VI e Pathologia e Gastroenterologia
city: Monza
country: Italy
facility: ASST Monza - Ospedale San Gerardo, Gastroenterologia
city: Padova
country: Italy
facility: Azienda Ospedale- Università degli Studi di Padova UOC Gastroenterologia
city: Palermo
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico P. Giaccone, UOC di Gastroenterologia-Dip.Medicina Interna e Specialistica
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre
state: Western Cape
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital, University of Cape Town - Clinical Research Centre
state: Western Cap
city: Cape Town
country: South Africa
facility: Mediclinic Constantiaberg, North Suites
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Madrid
country: Spain
facility: Hospital Universitario Puerta de Hierro -Madrid
city: Pontevedra
country: Spain
facility: Complexo Hospitalario Universitario de Pontevedra
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Bern
country: Switzerland
facility: Inselspital, Universitätsspital Bern Universitätsklinik für Viszerale chirurgie und Medizin Hepatologie
city: Lugano
country: Switzerland
facility: Fondazione Epatocentro Ticino
city: İzmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
state: Bornova
city: Istanbul
country: Turkey
facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi, Gastroentoloji Bilim Dali
state: Pendik
city: Ankara
country: Turkey
facility: Hacette Universitesi Hastenesi IC, Hastaliklari Anabilim Dali, Gastronenteroloji Bilim Dali, Mithapasa Cad. Hacettepe Mah.
city: Newcastle-upon-Tyne
country: United Kingdom
facility: The Newcastle upon Tyne Hospitals NHS Foundation Trust-Freeman Hospital
state: Newcastle
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust-Royal Victoria Hospital
city: Camberley
country: United Kingdom
facility: Frimley Health NHS Foundation Trust - Frimley Park Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust , Hull Royal Infirmary
city: London
country: United Kingdom
facility: King's College Hospital. King's College NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust - Queen's Medical Centre (QMC)
city: Plymouth
country: United Kingdom
facility: Plymouth Hospitals NHS Trust, Derriford Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: