Clinical trial NCT06589986: A Study to Assess the Efficacy and Safety of RO7790121 for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Moderately to Severely Active Ulcerative Colitis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Chugai Pharmaceutical
First posted: 2024-09-19
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of RO7790121 compared with placebo in participants with moderately to severely active ulcerative colitis (UC).


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of UC
* Moderately to severely active UC assessed by mMS
* Bodyweight \>= 40 kilogram (kg)
* Up to date with colorectal cancer (CRC) screening performed according to local standards
* Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
* Males and females of childbearing potential must meet protocol criteria for contraception requirements

Exclusion Criteria:

* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
* Presence of an ostomy or ileoanal pouch
* Current diagnosis or suspicion of primary sclerosing cholangitis
* Pregnancy or breastfeeding, or intention of becoming pregnant during the study
* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy

Primary outcomes:
measure: Percentage of Participants with Clinical Remission at Week 12
timeFrame: At Week 12
measure: Percentage of Participants with Clinical Remission at Week 52
timeFrame: At Week 52
Secondary outcomes:
measure: Change in Partial Modified Mayo Score (pmMS)
timeFrame: Baseline to Week 2
measure: Percentage of Participants with Endoscopic Improvement
timeFrame: At Week 12
measure: Percentage of Participants with Endoscopic Remission
timeFrame: At Week 12
measure: Percentage of Participants with Clinical Response
timeFrame: At Week 12
measure: Percentage of Participants with Histologic Improvement
timeFrame: At Week 12
measure: Percentage of Participants with Histologic Remission
timeFrame: At Week 12
measure: Percentage of Participants with Histologic-Endoscopic Mucosal Improvement
timeFrame: At Week 12
measure: Percentage of Participants with Histologic-Endoscopic Remission
timeFrame: At Week 12
measure: Percentage of Participants with Maintenance of Remission
timeFrame: Week 12 and Week 52
measure: Percentage of Participants with Corticosteroid-Free Remission
timeFrame: At Week 52
measure: Percentage of Participants with Endoscopic Improvement
timeFrame: At Week 52
measure: Percentage of Participants with Endoscopic Remission
timeFrame: At Week 52
measure: Percentage of Participants with Histologic Improvement
timeFrame: At Week 52
measure: Percentage of Participants with Histologic Remission
timeFrame: At Week 52
measure: Percentage of Participants with Histologic-Endoscopic Mucosal Improvement
timeFrame: At Week 52
measure: Percentage of Participants with Histologic-Endoscopic Remission
timeFrame: At Week 52
measure: Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants
timeFrame: At Week 12
measure: Percentage of Participants with Clinical remission: Among Biomarker-Defined Subgroups of Participants
timeFrame: At Week 52
measure: Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
timeFrame: At Week 12
measure: Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
timeFrame: At Week 52
measure: Change in Bowel Urgency
timeFrame: Baseline through Week 52
measure: Change in Abdominal Pain
timeFrame: Baseline through Week 52
measure: Change in Fatigue
timeFrame: Baseline to Week 12 and Week 52
measure: Change in Health-Related Quality of Life
timeFrame: Baseline to Week 12 and Week 52
measure: Overall Change in UC Symptoms
timeFrame: Baseline to Week 2, Week 12, and Week 52
measure: Overall Severity in UC Symptoms
timeFrame: Baseline to Week 2, Week 12, and Week 52
measure: Incidence and Severity of Adverse Events (AEs)
timeFrame: Up to 70 Weeks after Baseline
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
state: Alabama
city: Sun City
country: United States
facility: Arizona Digestive Health, P.C (ADH)
state: Arizona
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Orange
country: United States
facility: University of California Irvine
state: California
city: San Francisco
country: United States
facility: UCSF/Medical Center at Mount Zion
state: California
city: Santa Clarita
country: United States
facility: Amicis Research Center
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Lone Tree
country: United States
facility: Peak Gastroenterology Surgery Center
state: Colorado
city: Brooksville
country: United States
facility: Access Research Institute
state: Florida
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Doral
country: United States
facility: J&A Clinical Research
state: Florida
city: Kissimmee
country: United States
facility: Clinical Research of Osceola, LLC
state: Florida
city: Lakeland
country: United States
facility: Auzmer Research
state: Florida
city: Miami Beach
country: United States
facility: Miami Beach Clinical Research Center
state: Florida
city: Miami
country: United States
facility: Homestead Associates in Research, Inc.
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research Institute, Inc
state: Florida
city: Miramar
country: United States
facility: Eminat Research Group
state: Florida
city: Tampa
country: United States
facility: Nodal Medical Center, LLC
state: Florida
city: Tampa
country: United States
facility: Theia Clinical Research Centers, LLC
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia
state: Georgia
city: Idaho Falls
country: United States
facility: Grand Teton Research Group, PLLC
state: Idaho
city: Chicago
country: United States
facility: Next Innovative Clinical Research
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University Health University Hospital
state: Indiana
city: New Albany
country: United States
facility: Gastroenterology Health Partners, PLLC
state: Indiana
city: Crestview Hills
country: United States
facility: Tri-State Gastroenterology Associates
state: Kentucky
city: Louisville
country: United States
facility: Gastroenterology Health Partners, PLLC
state: Kentucky
city: Shreveport
country: United States
facility: Louisiana Research Center - GastroIntestinal Associates
state: Louisiana
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Boston
country: United States
facility: Brigham & Womens Hosp
state: Massachusetts
city: Boston
country: United States
facility: Boston University
state: Massachusetts
city: Farmington Hills
country: United States
facility: Michigan Center of Medical Research
state: Michigan
city: Flowood
country: United States
facility: Allied Gastrointestinal Associates, PA
state: Mississippi
city: Oxford
country: United States
facility: Gastroenterology Associates and Endoscopy Center of North Mississippi
state: Mississippi
city: Liberty
country: United States
facility: BVL Clinical Research
state: Missouri
city: Fresh Meadows
country: United States
facility: Intercity Gastroenterology
state: New York
city: New York
country: United States
facility: Pioneer Clinical Research NY
state: New York
city: New York
country: United States
facility: New York-Presbyterian Hospital-Columbia University Medical Center
state: New York
city: Asheville
country: United States
facility: Digestive Health Partners, PA
state: North Carolina
city: High Point
country: United States
facility: Peters Medical Research (PMR), LLC
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Brunswick
country: United States
facility: Digestive Disease Consultants
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio Gastroenterology Group
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Westlake
country: United States
facility: Gastro Intestinal Research Institute of Northern Ohio
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Providence
country: United States
facility: University Gastroenterology
state: Rhode Island
city: Cordova
country: United States
facility: Gastro One
state: Tennessee
city: Johnson City
country: United States
facility: Gastrointestinal Associates of Northeast Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Cedar Park
country: United States
facility: Texas Digestive Disease Consultants - Cedar Park
state: Texas
city: El Paso
country: United States
facility: Proactive El Paso,LLC
state: Texas
city: Garland
country: United States
facility: GI Alliance
state: Texas
city: Mansfield
country: United States
facility: TDDC dba GI Alliance Research
state: Texas
city: Pasadena
country: United States
facility: Digestive System Healthcare - Biopharma Informatic, LLC
state: Texas
city: San Antonio
country: United States
facility: Carta - Clinical Associates In Research Therapeutics Of America;LLC
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC.
state: Texas
city: Southlake
country: United States
facility: GI Alliance - Southlake
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Tyler
country: United States
facility: University of Texas Health Center at Tyler
state: Texas
city: Chesapeake
country: United States
facility: Tidewater Gastroenterology Pllc T/A Gastro. Assoc. of Tidewater
state: Virginia
city: Roanoke
country: United States
facility: Gastroenterology Consultants and Endoscopy Center of Southwest Virginia
state: Virginia
city: Huntington
country: United States
facility: Marshall Health
state: West Virginia
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: CIPREC Centro de Investigacion y Prevencion Cardiovascular
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Expertia S.A- Mautalen Salud e Investigación
city: Sydney
country: Australia
facility: Royal Prince Alfred Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Limited
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Lyell McEwin Hospital
state: South Australia
city: Epping
country: Australia
facility: Northern Hospital
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Innsbruck
country: Austria
facility: Medizinische Universität Innsbruck
city: Wien
country: Austria
facility: Barmherzige Brüder Wien
city: Wien
country: Austria
facility: Medizinische Universität Wien
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Gent
country: Belgium
facility: AZ Maria Middelares
city: Liege
country: Belgium
facility: CHC MontLégia
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Roeselare
country: Belgium
facility: AZ Delta (Campus Rumbeke)
city: Sint Niklaas
country: Belgium
facility: Vitaz
city: Gorna Oryahovitsa
country: Bulgaria
facility: MHAT St. Ivan Rilski
city: Plovdiv
country: Bulgaria
facility: MHAT Kaspela
city: Edmonton
country: Canada
facility: South Edmonton Gastroenterology
state: Alberta
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre
state: Nova Scotia
city: Woodbridge
country: Canada
facility: TDDA Specialty Research
state: Ontario
city: Concepcion
country: Chile
facility: Hospital Guillermo Grant Benavente
city: Santiago
country: Chile
facility: Clinica Universidad de Los Andes
city: Santiago
country: Chile
facility: Medwal
city: Binzhou
country: China
facility: Binzhou Medical university hospital
city: Changchun
country: China
facility: the First Hospital of Jilin University
city: Chengdu
country: China
facility: Sichuan Provincial People's Hospital
city: Fuzhou City
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
city: Guangzhou City
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
city: Guangzhou City
country: China
facility: The sixth affiliated hospital of Sun Yat-Sen University
city: Hefei
country: China
facility: Anhui Provincial Hospital
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
city: Huizhou
country: China
facility: Huizhou First Hospital
city: Jinhua
country: China
facility: Jinhua municipal central hospital
city: Nanchang City
country: China
facility: The 1st Affiliated Hospital of Nanchang Unversity
city: Nanjing
country: China
facility: Nanjing 1st Hospital
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Shijiazhuang City
country: China
facility: Hebei Medical University - The Second Hospital
city: Taiyuan
country: China
facility: The First Hospital of Shanxi Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan City
country: China
facility: Wuhan Union Hospital Tongji Medical College, Huazhong University of Science and Technology
city: Wuhan
country: China
facility: Ren Min Hospital Affiliated Wu Han University
city: Wuxi
country: China
facility: Wuxi People's Hospital
city: Xi'an City
country: China
facility: The Second Affiliated Hospital of Xi'an Jiao Tong University
city: Zhengzhou
country: China
facility: The Second Affiliated Hospital of Zhengzhou University
city: Zhuzhou
country: China
facility: Zhuzhou Central Hospital
city: Osijek
country: Croatia
facility: Borzan Polyclinic
city: Brno
country: Czechia
facility: SurGal Clinic s.r.o.
city: Ceske Budejovice
country: Czechia
facility: Nemocnice Ceske Budejovice a.s.
city: Hradec Kralove
country: Czechia
facility: Gastroenterologie s.r.o.
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Køge
country: Denmark
facility: Sjaellands Universitetshospital, Køge
city: Amiens
country: France
facility: CHU Amiens - Hopital Sud
city: Dijon
country: France
facility: CHU Dijon Bourgogne Hôpital François Mitterand
city: La Roche Sur Yon
country: France
facility: CH Dptal Les Oudairies
city: Lille
country: France
facility: CHRU de Lille - Hopital Claude Huriez
city: Marseille
country: France
facility: Hopital Nord
city: Neuilly sur Seine
country: France
facility: Institut des MICI, Clinique Ambroise Paré
city: Nice
country: France
facility: CHU Nice - Hopital de l'Archet 2
city: Pessac
country: France
facility: CHU Bordeaux - Hôpital Haut-Lévêque
city: Pierre-Benite
country: France
facility: Centre Hospitalier Lyon Sud
city: Reims
country: France
facility: Hopital Robert Debre
city: Rennes
country: France
facility: CHU de Rennes - Hopital de Pontchaillo
city: Saint Etienne
country: France
facility: CHU Saint Etienne - Hôpital Nord
city: Toulouse
country: France
facility: Hôpital de Rangueil
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
city: Frankfurt
country: Germany
facility: Klinik Johann Wolfgang von Goethe Uni
city: Halle
country: Germany
facility: Universitaetsklinikum Halle (Saale)
city: Jena
country: Germany
facility: Universitaetsklinikum Jena
city: Mannheim
country: Germany
facility: Klinikum Mannheim GmbH Universitätsklinikum
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Budapest
country: Hungary
facility: Obudai Egeszsegugyi Centrum Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum
city: Békéscsaba
country: Hungary
facility: Bekes Varmegyei Kozponti Korhaz, dr Rethy Pal Tagkorhaz
city: Eger
country: Hungary
facility: Heves County Markhot Ferenc Teaching Hospital
city: Gyöngyös
country: Hungary
facility: Gyöngyösi Bugát Pál Kórház
city: Szekszard
country: Hungary
facility: Clinfan Szolgaltato Kft.
city: Vác
country: Hungary
facility: Jávorszky Ödön Kórház
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
state: Bayit Vegan
city: Matera
country: Italy
facility: Ospedale Madonna delle Grazie
state: Basilicata
city: Catanzaro
country: Italy
facility: Azienda Ospedaliero-Universitaria "Renato Dulbecco" Catanzaro
state: Calabria
city: Napoli
country: Italy
facility: Universita'degli Studi di Napoli Federico II
state: Campania
city: Roma
country: Italy
facility: Policlinico Universitario Agostino Gemelli
state: Lazio
city: Milano
country: Italy
facility: Asst Santi Paolo E Carlo
state: Lombardia
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo di Pavia
state: Lombardia
city: Rho
country: Italy
facility: ASST Rhodense - Ospedale di Rho
state: Lombardia
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo della Soffenza
state: Lombardia
city: Torino
country: Italy
facility: Ospedale Mauriziano Umberto I
state: Piemonte
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: Veneto
city: Aomori
country: Japan
facility: National Hospital Organization Hirosaki General Medical Center
city: Chiba
country: Japan
facility: Tsujinaka Hospital Kashiwanoha
city: Chiba
country: Japan
facility: Toho University Sakura Medical Center
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Fukuoka
country: Japan
facility: Japan Organization of Occupational Health and Safety Kyushu Rosai Hospital
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center
city: Fukuoka
country: Japan
facility: Kurume University Hospital
city: Gifu
country: Japan
facility: Japanese Red Cross Takayama Hospital
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital
city: Hokkaido
country: Japan
facility: Sapporo Kosei General Hospital
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Kagawa
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Kagoshima-shi
country: Japan
facility: Sameshima Hospital
city: Kanagawa
country: Japan
facility: Yokohama City University Medical Center
city: Kanagawa
country: Japan
facility: Gokeikai Ofuna Chuo Hospital
city: Oita
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
city: Okayama-shi
country: Japan
facility: Okayama University Hospital
city: Ome-Shi
country: Japan
facility: Ome medical center
city: Osaka
country: Japan
facility: Kinshukai Infusion Clinic
city: Osaka
country: Japan
facility: National Hospital Organization Osaka National Hospital
city: Osaka
country: Japan
facility: Toyonaka Municipal Hospital
city: Osaka
country: Japan
facility: Kansai Medical University Hospital
city: Osaka
country: Japan
facility: Sai Gastroenterology/Proctology Clinic
city: Saga
country: Japan
facility: Saga-ken Medical Centre Koseikan
city: Saga
country: Japan
facility: Saga University Hospital
city: Saitama
country: Japan
facility: Tokitokai Tokito Clinic
city: Shizuoka
country: Japan
facility: Matsuda Hospital
city: Tokyo
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Tokyo
country: Japan
facility: NTT Medical Center Tokyo
city: Tokyo
country: Japan
facility: JCHO Tokyo Yamate Medical Center
city: Tokyo
country: Japan
facility: Tokai University Hachioji Hospital
city: Guadalajara
country: Mexico
facility: Boca Clinical Trials Mexico S.C. (Guadalajara)
state: Jalisco
city: Monterrey
country: Mexico
facility: Accelerium S. de R.L. de C.V.
state: Nuevo LEON
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht
city: ??czna
country: Poland
facility: SPZOZ w ??cznej
city: ?ód?
country: Poland
facility: Clinical Trials UMED Sp. z o. o.
city: Bia?ystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny W Bia?Ymstoku
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne "Medis"
city: Chojnice
country: Poland
facility: Centrum Medyczne Lukamed Joanna Luka-Wendrowska
city: Karczew
country: Poland
facility: Endo-Med Sp. z o.o.
city: Nowy Targ
country: Poland
facility: Allmedica Badania Kliniczne Sp z o.o. Sp K.
city: Olsztyn
country: Poland
facility: Wojewodzki Specjalistyczny Szpital w Olsztynie
city: Pabianice
country: Poland
facility: NZOZ Eskulap Pabianice
city: Piotrków Trybunalski
country: Poland
facility: Trialmed CRS
city: Pozna?
country: Poland
facility: SOLUMED Centrum Medyczne
city: Rzeszów
country: Poland
facility: Centrum Medyczne "MEDYK"
city: Sosnowiec
country: Poland
facility: Kiepury Clinic
city: Toru?
country: Poland
facility: Gastromed Sp. z o.o.
city: Warsaw
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny MSW w Warszawie
city: Wroc?aw
country: Poland
facility: Przychodnia EuroMediCare
city: Wroc?aw
country: Poland
facility: Vistamed & Vertigo Spó?Ka Z Ograniczon? Odpowiedzialno?Ci?
city: Wroclaw
country: Poland
facility: Melita Medical
city: Zamo??
country: Poland
facility: ETG Zamosc
city: Braga
country: Portugal
facility: Hospital de Braga
city: Lisboa
country: Portugal
facility: Hospital da Luz Lisboa
city: Portimao
country: Portugal
facility: Centro Hospitalar do Algarve - Hospital de Portimao
city: Porto
country: Portugal
facility: Hospital de Sao Joao
city: Santa Maria Da Feira
country: Portugal
facility: Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
city: Viseu
country: Portugal
facility: Hospital Sao Teotonio
city: Bucharest
country: Romania
facility: Colentina Clinical Hospital
city: Bucharest
country: Romania
facility: Cantacuzino Clinical Hospital
city: Belgrade
country: Serbia
facility: University Hospital Center Dr Dragisa Misovic - Dedinje
city: Belgrade
country: Serbia
facility: University Hospital Medical Center Zvezdara
city: Beograd
country: Serbia
facility: University Hospital Medical Center Bezanijska Kosa
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: Novi Sad
country: Serbia
facility: Clinical Center of Vojvodina
city: Bratislava
country: Slovakia
facility: Cliniq s.r.o.
city: Bratislava
country: Slovakia
facility: ABAWI spol. s r.o.
city: Bratislava
country: Slovakia
facility: Nemocnica Bory -Penta Hospitals
city: Košice
country: Slovakia
facility: Endomed, s.r.o.
city: Ružomberok
country: Slovakia
facility: Ustredna vojenska nemocnica SNP Ruzomberok ? FN
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Bangkok
country: Thailand
facility: Division of Gastroenterology, Depart of Medicine, Fac of Med., Chulalongkorn University
city: Bangkok
country: Thailand
facility: Division of Gastroenterology, Depart of Internal Med, Siriraj H, Mahidol Uni
city: Khon Kaen
country: Thailand
facility: Liver Research Unit, Srinagarind Hospital
city: Pathumthani
country: Thailand
facility: Thammasat University Hospital
city: Songkhla
country: Thailand
facility: Division of Gastroenterology, Depart of Medicine, Fac. of Med, Songklanagarind University
city: Surin
country: Thailand
facility: Surin hospital
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool University Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Queen Anne Street Medical Centre
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: