A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

Study Purpose

This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 (milligrams) by subcutaneous (SC) injection [SC] every 4 weeks [Q4W]) + placebo (intravenous [IV] infusion at Weeks 0, 2, and 6, then every 8 weeks) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then every 8 weeks) + placebo (SC Q4W). Time on treatment is 54 weeks.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS) - Naive to treatment with any anti-TNF inhibitor therapy (including TNF inhibitor biosimilars) - An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment - Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budenoside multi-matrix system (MMX), probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period - Use of highly effective contraception during and at least 24 weeks after the last dose of study drug

Exclusion Criteria:

- A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps - Prior or planned surgery for UC - Past or present ileostomy or colostomy - Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, efalizumab, and tofactinib) - History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies; fusion proteins, or murine proteins; hypersensitivity to etrolizumab or any of its excipients - Chronic hepatitis B or C infection, Human deficiency virus (HIV) or tuberculosis (active or latent)

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT02136069

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 3

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Hoffmann-La Roche

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Clinical Trials
Principal Investigator Affiliation Hoffmann-La Roche

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Netherlands, Norway, Philippines, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom, Vietnam

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Ulcerative Colitis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University Hospital Coventry, Coventry, United Kingdom

Status

Recruiting

Address

University Hospital Coventry

Coventry, , CV2 2DX

Addenbrooke's Hospital, Cambridge, United Kingdom

Status

Recruiting

Address

Addenbrooke's Hospital

Cambridge, , CB2 0QQ

Bristol Royal Infirmary, Bristol, United Kingdom

Status

Terminated

Address

Bristol Royal Infirmary

Bristol, , BS2 8HW

The Royal Bournemouth Hospital, Bournemouth, United Kingdom

Status

Active, not recruiting

Address

The Royal Bournemouth Hospital

Bournemouth, , BH7 7DW

Royal Victoria Hospital, Belfast, United Kingdom

Status

Not yet recruiting

Address

Royal Victoria Hospital

Belfast, , BT12 6BA

Basildon University Hospital, Basildon, United Kingdom

Status

Terminated

Address

Basildon University Hospital

Basildon, , SS16 5NL

Barnet Hospital, Barnet, United Kingdom

Status

Terminated

Address

Barnet Hospital

Barnet, , EN5 3DJ

Aberdeen Royal Infirmary, Aberdeen, United Kingdom

Status

Terminated

Address

Aberdeen Royal Infirmary

Aberdeen, , AB25 2ZN

Universitaetsspital Zuerich, Zürich, Switzerland

Status

Recruiting

Address

Universitaetsspital Zuerich

Zürich, , 8091

Kantonsspital St.Gallen, St. Gallen, Switzerland

Status

Recruiting

Address

Kantonsspital St.Gallen

St. Gallen, , 9007

Inselspital-Universitaetsspital Bern, Bern, Switzerland

Status

Recruiting

Address

Inselspital-Universitaetsspital Bern

Bern, , 3010

Spital Netz Bern AG- Spital Tiefenau, Bern, Switzerland

Status

Withdrawn

Address

Spital Netz Bern AG- Spital Tiefenau

Bern, , 3004

Akademiska Sjukhuset; Infektionskliniken, Uppsala, Sweden

Status

Recruiting

Address

Akademiska Sjukhuset; Infektionskliniken

Uppsala, , 751 85

Danderyds Sjukhus AB, Stockholm, Sweden

Status

Recruiting

Address

Danderyds Sjukhus AB

Stockholm, , 18288

Karolinska, Stockholm, Sweden

Status

Terminated

Address

Karolinska

Stockholm, , 17176

Capio S:t Görans sjukhus, Stockholm, Sweden

Status

Withdrawn

Address

Capio S:t Görans sjukhus

Stockholm, , 11281

Skånes Universitetssjukhus, Lund, Sweden

Status

Withdrawn

Address

Skånes Universitetssjukhus

Lund, , 221 85

Hospital Universitario Miguel Servet, Zaragoza, Spain

Status

Withdrawn

Address

Hospital Universitario Miguel Servet

Zaragoza, , 50009

Hospital Universitari i Politecnic La Fe, Valencia, Spain

Status

Recruiting

Address

Hospital Universitari i Politecnic La Fe

Valencia, , 46026

Complejo Hospitalario de Pontevedra, Pontevedra, Spain

Status

Terminated

Address

Complejo Hospitalario de Pontevedra

Pontevedra, , 36071

Hospital Universitario de Fuenlabrada, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de Fuenlabrada

Madrid, , 28942

Madrid, Spain

Status

Terminated

Address

Hospital Universitario Clínico San Carlos

Madrid, , 28040

Hospital Universitario La Paz, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario La Paz

Madrid, , 280146

Hospital Universitario de la Princesa, Madrid, Spain

Status

Recruiting

Address

Hospital Universitario de la Princesa

Madrid, , 28006

Girona, Spain

Status

Recruiting

Address

Hospital Universitari de Girona Dr Josep Trueta

Girona, , 17007

Centro Médico Teknon, Barcelona, Spain

Status

Recruiting

Address

Centro Médico Teknon

Barcelona, ,

Barcelona, Spain

Status

Terminated

Address

Hospital Clinic de Barcelona; Servicio de Farmacia

Barcelona, , 08036

Hospital del Mar, Barcelona, Spain

Status

Terminated

Address

Hospital del Mar

Barcelona, , 08003

Alicante, Spain

Status

Terminated

Address

Hospital General Universitario de Alicante

Alicante, , 03010

Alcorcon, Madrid, Spain

Status

Recruiting

Address

Fundacion Hospital de Alcorcon; Servicio de Digestivo

Alcorcon, Madrid, 28922

Ferrol, LA Coruña, Spain

Status

Recruiting

Address

Complejo Hospitalario Universitario de Ferrol

Ferrol, LA Coruña, 15405

Corporacio Sanitaria Parc Tauli, Sabadell, Barcelona, Spain

Status

Not yet recruiting

Address

Corporacio Sanitaria Parc Tauli

Sabadell, Barcelona, 08208

Hospital Universitario de Bellvitge, Hospitalet de Llobregat, Barcelona, Spain

Status

Withdrawn

Address

Hospital Universitario de Bellvitge

Hospitalet de Llobregat, Barcelona, 08907

CCM Ziady Practice, Pretoria, South Africa

Status

Terminated

Address

CCM Ziady Practice

Pretoria, , 0181

Pretoria, South Africa

Status

Terminated

Address

Steve Biko Academic Hospital, Department of Surgery

Pretoria, , 0084

Dr P Barrow Practice, Johannesburg, South Africa

Status

Terminated

Address

Dr P Barrow Practice

Johannesburg, , 2193

Dr HR Schneider Practice, Johannesburg, South Africa

Status

Terminated

Address

Dr HR Schneider Practice

Johannesburg, , 2193

Dr N Aboo Practice, Durban, South Africa

Status

Terminated

Address

Dr N Aboo Practice

Durban, , 4091

Precise Clinical Solutions (Pty) Ltd, Chatsworth, South Africa

Status

Recruiting

Address

Precise Clinical Solutions (Pty) Ltd

Chatsworth, , 4092

Cape Town, South Africa

Status

Withdrawn

Address

Groote Schuur Hospital Gastroenterology Department

Cape Town, , 7925

Cape Town, South Africa

Status

Withdrawn

Address

Smit, GJJ; Department of Internal Medicine

Cape Town, , 7800

Dr Corne Kruger Inc., Cape Town, South Africa

Status

Active, not recruiting

Address

Dr Corne Kruger Inc.

Cape Town, , 7550

Dr MJ Prins Practice, Cape Town, South Africa

Status

Recruiting

Address

Dr MJ Prins Practice

Cape Town, , 7500

Dr D Epstein Practice, Cape Town, South Africa

Status

Withdrawn

Address

Dr D Epstein Practice

Cape Town, , 7405

Netcare Universitas Private Hospital, Bloemfontein, South Africa

Status

Recruiting

Address

Netcare Universitas Private Hospital

Bloemfontein, , 9301

Changi General Hospital, Singapore, Singapore

Status

Recruiting

Address

Changi General Hospital

Singapore, , 529889

Singapore, Singapore

Status

Recruiting

Address

Tan Tock Seng Hospital; CTRU/OCS, Research

Singapore, , 308433

Singapore General Hospital, Singapore, Singapore

Status

Recruiting

Address

Singapore General Hospital

Singapore, , 169608

Timisoara, Romania

Status

Terminated

Address

Spitalul Clinic Judetean de Urgenta Timisoara

Timisoara, , 300736

Centrul de Gastroenterologie Dr. Goldis, Timisoara, Romania

Status

Completed

Address

Centrul de Gastroenterologie Dr. Goldis

Timisoara, , 300002

Spitalul Clinic Judetean Mures, Targu Mures, Romania

Status

Recruiting

Address

Spitalul Clinic Judetean Mures

Targu Mures, , 540103

Iasi, Romania

Status

Withdrawn

Address

Institutul de Gastroenterologie si Hepatologie Iasi

Iasi, , 700111

Craiova, Romania

Status

Terminated

Address

Spitalul Clinic Judetean de Urgenta Craiova

Craiova, , 200642

Cluj-Napoca, Romania

Status

Terminated

Address

Institutul Regional de Gastroenterologie si Hepatologie Prof. Dr. Octavian Fodor

Cluj-Napoca, , 400162

Cluj-Napoca, Romania

Status

Terminated

Address

Spitalul Clinic Judetean de Urgenta Cluj Napoca

Cluj-Napoca, , 400006

Bucuresti, Romania

Status

Recruiting

Address

Spitalul Universitar de Urgenta Bucuresti; Clinica Medicina Interna II - Gastroenterologie

Bucuresti, , 50098

Centrul Medical Unirea SRL, Bucuresti, Romania

Status

Recruiting

Address

Centrul Medical Unirea SRL

Bucuresti, , 040055

SC Euroclinic Hospital SA, Bucuresti, Romania

Status

Terminated

Address

SC Euroclinic Hospital SA

Bucuresti, , 014461

Bucuresti, Romania

Status

Terminated

Address

Spitalul Universitar de Urgenta Militar Central Dr Carol Davila

Bucuresti, , 010825

S.C MedLife S.A, Bucuresti, Romania

Status

Recruiting

Address

S.C MedLife S.A

Bucuresti, , 010719

Spitalul Clinic Colentina, Bucharest, Romania

Status

Recruiting

Address

Spitalul Clinic Colentina

Bucharest, , 772202

Institutul Clinic Fundeni Bucuresti, Bucharest, Romania

Status

Not yet recruiting

Address

Institutul Clinic Fundeni Bucuresti

Bucharest, , 022328

Institutul Clinic Fundeni Bucuresti, Bucharest, Romania

Status

Recruiting

Address

Institutul Clinic Fundeni Bucuresti

Bucharest, , 022328

Spitalul Clinic Dr. I Cantacuzino, Bucharest, Romania

Status

Terminated

Address

Spitalul Clinic Dr. I Cantacuzino

Bucharest, , 020475

Viseu, Portugal

Status

Withdrawn

Address

Hospital Sao Teotonio; Servico de Gastroenterologia

Viseu, , 3504-509

Setúbal, Portugal

Status

Not yet recruiting

Address

Centro Hospitalar de Setúbal, EPE - Hospital São Bernardo

Setúbal, , 2910-446

Loures, Portugal

Status

Recruiting

Address

Hospital Beatriz Angelo; Servico de Gastrenterologia

Loures, , 2674-514

Lisboa, Portugal

Status

Terminated

Address

Hospital da Luz; Departamento de Oncologia Medica

Lisboa, , 1500-650

Guimarães, Portugal

Status

Active, not recruiting

Address

Hospital da Senhora da Oliveira Guimarães

Guimarães, , 4835-044

Coimbra, Portugal

Status

Recruiting

Address

Centro Hospitalar E Universitário de Coimbra EPE

Coimbra, , 3000-602

Hospital de Braga, Braga, Portugal

Status

Active, not recruiting

Address

Hospital de Braga

Braga, , 4710-243

Almada, Portugal

Status

Recruiting

Address

Hospital Garcia de Orta; Servico de Neurologia

Almada, , 2801-951

Cardinal Santos Medical Center, San Juan, Philippines

Status

Terminated

Address

Cardinal Santos Medical Center

San Juan, , 1502

Universitetssykehuset Nord-Norge, Tromso, Norway

Status

Withdrawn

Address

Universitetssykehuset Nord-Norge

Tromso, , 9019

Akershus universitetssykehus HF, Lørenskog, Norway

Status

Recruiting

Address

Akershus universitetssykehus HF

Lørenskog, , 1478

Zuyderland ziekenhuis locatie Geleen, Sittard-Geleen, Netherlands

Status

Withdrawn

Address

Zuyderland ziekenhuis locatie Geleen

Sittard-Geleen, , 6162 BG

Radboudumc, NL -nijmegen, Netherlands

Status

Recruiting

Address

Radboudumc

NL -nijmegen, , 6525 GA

Maastricht University Medical Center, Maastricht, Netherlands

Status

Recruiting

Address

Maastricht University Medical Center

Maastricht, , 6229 HX

Rijnstate; Internal Medicine Department, Arnhem, Netherlands

Status

Terminated

Address

Rijnstate; Internal Medicine Department

Arnhem, , 6815 AD

Amsterdam UMC Location AMC, Amsterdam, Netherlands

Status

Recruiting

Address

Amsterdam UMC Location AMC

Amsterdam, , 1105 AZ

Onze Lieve Vrouwe Gasthuis, locatie Oost, Amsterdam, Netherlands

Status

Terminated

Address

Onze Lieve Vrouwe Gasthuis, locatie Oost

Amsterdam, , 1091 AC

Amsterdam UMC Location VUMC, Amsterdam, Netherlands

Status

Recruiting

Address

Amsterdam UMC Location VUMC

Amsterdam, , 1081 HV

Alkmaar, Netherlands

Status

Not yet recruiting

Address

Noordwest Ziekenhuisgroep; Pulmonology 117

Alkmaar, , 1815 JD

Wonju-Si, Korea, Republic of

Status

Recruiting

Address

Yonsei University Wonju Severance Christian Hospital

Wonju-Si, , 220-701

Suwon-si,, Korea, Republic of

Status

Recruiting

Address

The Catholic University of Korea St. Vincent's Hospital

Suwon-si,, , 442-723

Samsung Medical Center, Seoul, Korea, Republic of

Status

Completed

Address

Samsung Medical Center

Seoul, , 6351

Seoul, Korea, Republic of

Status

Terminated

Address

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, , 156-707

Asan Medical Center - Oncology, Seoul, Korea, Republic of

Status

Recruiting

Address

Asan Medical Center - Oncology

Seoul, , 05505

Severance Hospital, Yonsei University, Seoul, Korea, Republic of

Status

Recruiting

Address

Severance Hospital, Yonsei University

Seoul, , 03722

Kangbuk Samsung Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Kangbuk Samsung Hospital

Seoul, , 03181

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seoul, , 03080

Kyung Hee University Hospital, Seoul, Korea, Republic of

Status

Recruiting

Address

Kyung Hee University Hospital

Seoul, , 02447

Seongnam, Korea, Republic of

Status

Recruiting

Address

CHA Bundang Medical Centre; CHA university

Seongnam, , 13520

Ajou University Hospital, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Ajou University Hospital

Gyeonggi-do, , 443-380

Korea University Ansan Hospital, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Korea University Ansan Hospital

Gyeonggi-do, , 15355

Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Seoul National University Bundang Hospital

Gyeonggi-do, , 13620

Hanyang University Guri Hospital, Gyeonggi-do, Korea, Republic of

Status

Recruiting

Address

Hanyang University Guri Hospital

Gyeonggi-do, , 11923

Konyang University Hospital, Daejeon, Korea, Republic of

Status

Terminated

Address

Konyang University Hospital

Daejeon, , 302-718

Yeungnam Univ. Hospital, Daegu, Korea, Republic of

Status

Recruiting

Address

Yeungnam Univ. Hospital

Daegu, , 705-717

Kyungpook National University Hospital, Daegu, Korea, Republic of

Status

Recruiting

Address

Kyungpook National University Hospital

Daegu, , 41944

Daegu, Korea, Republic of

Status

Recruiting

Address

Keimyung University Dongsan Medical Center

Daegu, , 41931

Daegu, Korea, Republic of

Status

Recruiting

Address

Kyungpook National University Chilgok Hospital

Daegu, , 41404

Pusan National University Hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Pusan National University Hospital

Busan, , 49241

Dong-A University Hospital, Busan, Korea, Republic of

Status

Recruiting

Address

Dong-A University Hospital

Busan, , 49201

Azienda Ospedaliera Di Padova, Padova, Veneto, Italy

Status

Recruiting

Address

Azienda Ospedaliera Di Padova

Padova, Veneto, 35128

Ospedale S. Martino, Belluno, Veneto, Italy

Status

Recruiting

Address

Ospedale S. Martino

Belluno, Veneto, 32100

Azienda Ospedaliero Universitaria Pisana, Pisa, Toscana, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Pisana

Pisa, Toscana, 56100

Firenze, Toscana, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Careggi

Firenze, Toscana, 50141

Azienda Ospedaliera Vincenzo Cervello, Palermo, Sicilia, Italy

Status

Recruiting

Address

Azienda Ospedaliera Vincenzo Cervello

Palermo, Sicilia, 90127

Messina, Sicilia, Italy

Status

Recruiting

Address

Nefrologia; Azienda Ospedaliera Universitaria Policlinico G. Martino

Messina, Sicilia, 98125

Ospedale Mauriziano Umberto I, Torino, Piemonte, Italy

Status

Recruiting

Address

Ospedale Mauriziano Umberto I

Torino, Piemonte, 10128

San Giovanni Rotondo, Lombardia, Italy

Status

Recruiting

Address

IRCCS Ospedale Casa Sollievo della Soffenza; Stru Comp di Gastroenterologia ed Endoscopia digest

San Giovanni Rotondo, Lombardia, 71013

I.R.C.C.S Policlinico San Donato, San Donato Milanese (MI), Lombardia, Italy

Status

Recruiting

Address

I.R.C.C.S Policlinico San Donato

San Donato Milanese (MI), Lombardia, 20097

Istituto Clinico Humanitas, Rozzano (MI), Lombardia, Italy

Status

Recruiting

Address

Istituto Clinico Humanitas

Rozzano (MI), Lombardia, 20089

Fondazione IRCCS Policlinico San Matteo, Pavia, Lombardia, Italy

Status

Terminated

Address

Fondazione IRCCS Policlinico San Matteo

Pavia, Lombardia, 27100

Milano, Lombardia, Italy

Status

Recruiting

Address

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

Milano, Lombardia,

Milano, Lombardia, Italy

Status

Recruiting

Address

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

Milano, Lombardia, 20162

Milano, Lombardia, Italy

Status

Recruiting

Address

Asst Fatebenefratelli Sacco (Fatebenefratelli)

Milano, Lombardia, 20121

Genova, Liguria, Italy

Status

Terminated

Address

Azienda Ospedaliero Universitaria San Martino

Genova, Liguria, 16132

Roma, Lazio, Italy

Status

Recruiting

Address

Policlinico Universitario Agostino Gemelli

Roma, Lazio, 00168

Roma, Lazio, Italy

Status

Recruiting

Address

Azienda Ospedaliera San Camillo Forlanini

Roma, Lazio, 00152

Ospedale San Filippo Neri, Roma, Lazio, Italy

Status

Withdrawn

Address

Ospedale San Filippo Neri

Roma, Lazio, 00135

Roma, Lazio, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Roma, Lazio, 00133

Udine, Friuli-Venezia Giulia, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliero-Universitaria Santa Maria della Misericordia

Udine, Friuli-Venezia Giulia, 33100

Parma, Emilia-Romagna, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria di Parma

Parma, Emilia-Romagna, 43100

A.O.U. Policlinico di Modena, Modena, Emilia-Romagna, Italy

Status

Recruiting

Address

A.O.U. Policlinico di Modena

Modena, Emilia-Romagna, 40124

Bologna, Emilia-Romagna, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

Bologna, Emilia-Romagna, 40138

The Baruch Padeh MC, Poriya, Tiberias, Israel

Status

Terminated

Address

The Baruch Padeh MC, Poriya

Tiberias, ,

Tel Aviv, Israel

Status

Recruiting

Address

Tel Aviv Sourasky Medical Ctr; Gastroenterology Department

Tel Aviv, , 0064239

Kaplan Medical Center, Rehovot, Israel

Status

Recruiting

Address

Kaplan Medical Center

Rehovot, , 7661041

Chaim Sheba Medical Center, Ramat Gan, Israel

Status

Recruiting

Address

Chaim Sheba Medical Center

Ramat Gan, , 5265601

Galilee Medical Center, Nahariya, Israel

Status

Not yet recruiting

Address

Galilee Medical Center

Nahariya, , 22100

Meir Medical Center, Kfar Saba, Israel

Status

Recruiting

Address

Meir Medical Center

Kfar Saba, , 4428164

Clalit Health Services-Lev Talpiyot, Jerusalem, Israel

Status

Terminated

Address

Clalit Health Services-Lev Talpiyot

Jerusalem, , 95146

Shaare Zedek Medical Center, Jerusalem, Israel

Status

Not yet recruiting

Address

Shaare Zedek Medical Center

Jerusalem, , 9103102

Hillel Yaffe Medical Center, Hadera, Israel

Status

Not yet recruiting

Address

Hillel Yaffe Medical Center

Hadera, , 38100

Soroka University Medical Centre, Beer Sheva, Israel

Status

Withdrawn

Address

Soroka University Medical Centre

Beer Sheva, , 8410100

Barzilai Medical Center, Ashkelon, Israel

Status

Terminated

Address

Barzilai Medical Center

Ashkelon, , 78278

Zala Megyei Szent Rafael Korhaz, Zalaegerszeg, Hungary

Status

Not yet recruiting

Address

Zala Megyei Szent Rafael Korhaz

Zalaegerszeg, , 8900

Székesfehérvár, Hungary

Status

Recruiting

Address

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

Székesfehérvár, , 8000

Szeged, Hungary

Status

Recruiting

Address

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, , 6720

Nyiregyhaza, Hungary

Status

Withdrawn

Address

SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

Nyiregyhaza, , 4400

Mohacsi Korhaz, Mohacs, Hungary

Status

Withdrawn

Address

Mohacsi Korhaz

Mohacs, , 7700

Miskolc, Hungary

Status

Completed

Address

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz; II. Belgyogyaszat

Miskolc, , 3526

Petz Aladar Megyei Oktato Korhaz, Gyor, Hungary

Status

Recruiting

Address

Petz Aladar Megyei Oktato Korhaz

Gyor, , 9024

Eger, Hungary

Status

Recruiting

Address

Markhot Ferenc Oktato Korhaz es Rendelointezet

Eger, , 3300

Debrecen, Hungary

Status

Completed

Address

Vasutegeszsegugyi Nonprofit KiemeltenKozhasznu Kft

Debrecen, , 4025

Budapest, Hungary

Status

Recruiting

Address

Magyar Honvedseg Egeszsegugyi Kozpont; Fázis I-es Klinikai Farmakológiai Vizsgálóhely

Budapest, , H-1077

Budapest, Hungary

Status

Terminated

Address

Szt Janos Korhaz es EbudaiEgyesitettKorhazak

Budapest, , 1125

Budapest, Hungary

Status

Recruiting

Address

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

Budapest, , 1125

Semmelweis Egyetem, Budapest, Hungary

Status

Recruiting

Address

Semmelweis Egyetem

Budapest, , 1083

Obudai Egeszsegugyi Centrum Kft., Budapest, Hungary

Status

Not yet recruiting

Address

Obudai Egeszsegugyi Centrum Kft.

Budapest, , 1036

Bekescsaba, Hungary

Status

Recruiting

Address

Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaza

Bekescsaba, , 5600

Universitaetsklinikum Ulm, Ulm, Germany

Status

Recruiting

Address

Universitaetsklinikum Ulm

Ulm, , 89081

Mainz, Germany

Status

Recruiting

Address

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

Mainz, , 55101

Lübeck, Germany

Status

Not yet recruiting

Address

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

Lübeck, , 23538

Universitätsklinikum Koeln, Koeln, Germany

Status

Recruiting

Address

Universitätsklinikum Koeln

Koeln, , 50937

Kiel, Germany

Status

Recruiting

Address

Universitaetsklinikum Schleswig-Holstein, Campus Kiel

Kiel, , 24116

Herne, Germany

Status

Terminated

Address

Gastroenterologische Gemeinschaftspraxis Herne

Herne, , 44623

Asklepios Klinik Hamburg, Hamburg, Germany

Status

Withdrawn

Address

Asklepios Klinik Hamburg

Hamburg, , 22559

Gastroenterologie, Hamburg, Germany

Status

Recruiting

Address

Gastroenterologie

Hamburg, , 20249

Hamburg, Germany

Status

Recruiting

Address

Hamburgisches Forschungsinstitut fuer CED

Hamburg, , 20148

Universitaetsklinikum Halle (Saale), Halle, Germany

Status

Recruiting

Address

Universitaetsklinikum Halle (Saale)

Halle, , 06120

Universitaetsklinikum Freiburg, Freiburg, Germany

Status

Recruiting

Address

Universitaetsklinikum Freiburg

Freiburg, , 79106

Universitätsklinikum Essen, Essen, Germany

Status

Not yet recruiting

Address

Universitätsklinikum Essen

Essen, , 45147

Braunschweig, Germany

Status

Terminated

Address

Staedtisches Klinikum Braunschweig gGmbH - Standort Salzdahlumer

Braunschweig, , 38126

Staedisches Klinikum Brandenburg, Brandenburg an der Havel, Germany

Status

Recruiting

Address

Staedisches Klinikum Brandenburg

Brandenburg an der Havel, , 14770

Krankenhaus Waldfriede e. V., Berlin, Germany

Status

Recruiting

Address

Krankenhaus Waldfriede e. V.

Berlin, , 14163

Krankenhaus Waldfriede Brustzentrum, Berlin, Germany

Status

Withdrawn

Address

Krankenhaus Waldfriede Brustzentrum

Berlin, , 14163

DRK Kliniken Berlin Westend, Berlin, Germany

Status

Completed

Address

DRK Kliniken Berlin Westend

Berlin, , 14050

Berlin, Germany

Status

Recruiting

Address

Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin

Berlin, , 12200

Berlin, Germany

Status

Not yet recruiting

Address

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, , 10117

Berlin, Germany

Status

Withdrawn

Address

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, , 10117

Hôpital de Brabois Adultes, Vandoeuvre-les-nancy, France

Status

Recruiting

Address

Hôpital de Brabois Adultes

Vandoeuvre-les-nancy, , 54511

CHU de Toulouse - Hôpital Rangueil, Toulouse Cedex 09, France

Status

Recruiting

Address

CHU de Toulouse - Hôpital Rangueil

Toulouse Cedex 09, , 31059

Hopital Hautepierre - CHU Strasbourg, Strasbourg, France

Status

Recruiting

Address

Hopital Hautepierre - CHU Strasbourg

Strasbourg, , 67098

CHU Saint Etienne - Hôpital Nord, Saint Etienne, France

Status

Recruiting

Address

CHU Saint Etienne - Hôpital Nord

Saint Etienne, , 42055

CHU de Rouen - Hôpital Charles Nicolle, Rouen, France

Status

Not yet recruiting

Address

CHU de Rouen - Hôpital Charles Nicolle

Rouen, , 76031

CHU de Rennes - Hopital de Pontchaillo, Rennes, France

Status

Terminated

Address

CHU de Rennes - Hopital de Pontchaillo

Rennes, , 35033

CHU Robert Debre de Reims, Reims, France

Status

Recruiting

Address

CHU Robert Debre de Reims

Reims, , 51092

Pierre-Benite, France

Status

Recruiting

Address

Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie

Pierre-Benite, , 69495

CHU Bordeaux - Hôpital Haut-Lévêque, Pessac, France

Status

Recruiting

Address

CHU Bordeaux - Hôpital Haut-Lévêque

Pessac, , 33600

Hôpital Saint-Louis, Paris, France

Status

Recruiting

Address

Hôpital Saint-Louis

Paris, , 75475

CHU Nice - Hopital de l'Archet 2, Nice, France

Status

Recruiting

Address

CHU Nice - Hopital de l'Archet 2

Nice, , 06202

CHU NANTES - Hôtel Dieu; Pharmacy, Nantes, France

Status

Recruiting

Address

CHU NANTES - Hôtel Dieu; Pharmacy

Nantes, , 44093

CHU Hopital Saint Eloi, Montpellier, France

Status

Recruiting

Address

CHU Hopital Saint Eloi

Montpellier, , 34295

Hôpital Saint Joseph, Marseille, France

Status

Recruiting

Address

Hôpital Saint Joseph

Marseille, , 13008

Marseille Cedex 20, France

Status

Terminated

Address

Hôpital Nord - CHU Marseille; Service d'Oncologie Multidisciplinaire

Marseille Cedex 20, , 13915

Hopital Claude Huriez - CHU Lille, Lille, France

Status

Recruiting

Address

Hopital Claude Huriez - CHU Lille

Lille, , 59037

Le Kremlin Bicêtre cedex, France

Status

Not yet recruiting

Address

Groupement Hospitalier Sud - Hôpital Bicêtre

Le Kremlin Bicêtre cedex, , 94275

Creteil cedex, France

Status

Recruiting

Address

Centre Hospitalier Intercommunal de Créteil

Creteil cedex, , 94010

Hôpital Beaujon, Clichy cedex, France

Status

Recruiting

Address

Hôpital Beaujon

Clichy cedex, , 92110

CHU Clermont Ferrand - Hôtel Dieu, Clermont-Ferrand, France

Status

Recruiting

Address

CHU Clermont Ferrand - Hôtel Dieu

Clermont-Ferrand, , 63000

CHU Tours - Hôpital Trousseau, Chambray les Tours, France

Status

Recruiting

Address

CHU Tours - Hôpital Trousseau

Chambray les Tours, , 37170

CHU de Caen - Hopital Cote de Nacre, Caen, France

Status

Recruiting

Address

CHU de Caen - Hopital Cote de Nacre

Caen, , 14033

CHU Amiens - Hopital Sud, Amiens, France

Status

Recruiting

Address

CHU Amiens - Hopital Sud

Amiens, , 80054

Krajska nemocnice T. Bati, a.s., Zlin, Czechia

Status

Recruiting

Address

Krajska nemocnice T. Bati, a.s.

Zlin, , 76001

Usti Nad Labem, Czechia

Status

Recruiting

Address

Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni

Usti Nad Labem, , 401 13

ISCARE I.V.F. a.s., Praha 7, Czechia

Status

Recruiting

Address

ISCARE I.V.F. a.s.

Praha 7, , 170 04

Fakultni nemocnice v Motole, Praha 5, Czechia

Status

Recruiting

Address

Fakultni nemocnice v Motole

Praha 5, , 150 06

MEDICON a.s., Praha 4, Czechia

Status

Terminated

Address

MEDICON a.s.

Praha 4, , 140 40

Nemocnice Na Bulovce, Prague, Czechia

Status

Not yet recruiting

Address

Nemocnice Na Bulovce

Prague, , 180 01

Pardubicka krajska nemocnice, a.s., Pardubice, Czechia

Status

Recruiting

Address

Pardubicka krajska nemocnice, a.s.

Pardubice, , 532 03

Mestska Nemocnice Ostrava, Ostrava - Fifejdy, Czechia

Status

Recruiting

Address

Mestska Nemocnice Ostrava

Ostrava - Fifejdy, , 72880

Litomerice, Czechia

Status

Withdrawn

Address

Gastroenterologicka a Hepatologicka ambulance

Litomerice, , 412 01

Kladno, Czechia

Status

Recruiting

Address

Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum

Kladno, , 272 59

Fakultni nemocnice Hradec Kralove, Hradec Kralove, Czechia

Status

Recruiting

Address

Fakultni nemocnice Hradec Kralove

Hradec Kralove, , 500 05

Frydek Mistek, Czechia

Status

Terminated

Address

Nemocnice ve Frydku-Mistku, prispevkova organizace

Frydek Mistek, , 738 01

Vojenska nemocnice Brno, Brno, Czechia

Status

Recruiting

Address

Vojenska nemocnice Brno

Brno, , 636 00

Royal University Hospital, Saskatoon, Saskatchewan, Canada

Status

Recruiting

Address

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8

CHUS - Hôtel-Dieu, Sherbrooke, Quebec, Canada

Status

Withdrawn

Address

CHUS - Hôtel-Dieu

Sherbrooke, Quebec, J1G 2E8

Hôpital Maisonneuve - Rosemont, Montreal, Quebec, Canada

Status

Recruiting

Address

Hôpital Maisonneuve - Rosemont

Montreal, Quebec, H1T 2M4

Hotel Dieu de Levis, Levis, Quebec, Canada

Status

Terminated

Address

Hotel Dieu de Levis

Levis, Quebec, G6V 3Z1

Greenfield Park, Quebec, Canada

Status

Recruiting

Address

Centre de santé et de services sociaux Champlain-Charles-Le Moyne

Greenfield Park, Quebec, J4V 2H1

Toronto Liver Centre, Toronto, Ontario, Canada

Status

Recruiting

Address

Toronto Liver Centre

Toronto, Ontario, M6H 3M1

Mount Sinai Hospital, Toronto, Ontario, Canada

Status

Withdrawn

Address

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5

Humber River Hospital, Toronto, Ontario, Canada

Status

Terminated

Address

Humber River Hospital

Toronto, Ontario, M3M 0B2

Ottawa, Ontario, Canada

Status

Withdrawn

Address

The Ottawa Hospital - Riverside Campus; Gastrointestinal Clinical Research Unit

Ottawa, Ontario, K1H 1A2

Oshawa Clinic, Oshawa, Ontario, Canada

Status

Withdrawn

Address

Oshawa Clinic

Oshawa, Ontario, L1H 1B9

London, Ontario, Canada

Status

Terminated

Address

London Health Sciences Centre · Victoria Hospital; Research Pharmacy

London, Ontario, N6A 5W9

LHSC - University Hospital, London, Ontario, Canada

Status

Terminated

Address

LHSC - University Hospital

London, Ontario, N6A 5A5

London, Ontario, Canada

Status

Recruiting

Address

LHSC - University Hospital; Research Pharmacy

London, Ontario, N6A 5A5

London, Ontario, Canada

Status

Withdrawn

Address

London Health Sciences Centre; Victoria Hospital

London, Ontario, N6A 4G5

Hamilton, Ontario, Canada

Status

Terminated

Address

McMaster University Health Sciences Center

Hamilton, Ontario, L8N 3Z5

Guelph GI & Surgery Clinic, Guelph, Ontario, Canada

Status

Recruiting

Address

Guelph GI & Surgery Clinic

Guelph, Ontario, N1H 3R3

Bridgewater, Nova Scotia, Canada

Status

Terminated

Address

Pharmaceutical Integrated Research Corporation

Bridgewater, Nova Scotia, B4V 3N2

The Medical Arts Health Research Group, Powell River, British Columbia, Canada

Status

Withdrawn

Address

The Medical Arts Health Research Group

Powell River, British Columbia, V8A 3B6

Fraser Clinical Trials Inc., New Westminster, British Columbia, Canada

Status

Not yet recruiting

Address

Fraser Clinical Trials Inc.

New Westminster, British Columbia, V3L 3W4

South Edmonton Gastroenterology, Edmonton, Alberta, Canada

Status

Recruiting

Address

South Edmonton Gastroenterology

Edmonton, Alberta, T6L 6K3

Edmonton, Alberta, Canada

Status

Recruiting

Address

Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology

Edmonton, Alberta, T6G 2X8

Calgary, Alberta, Canada

Status

Recruiting

Address

University of Calgary; Heritage Medical Research Clinic

Calgary, Alberta, T2N 4Z6

AZ Delta (Stedelijk Ziekenhuis), Roeselare, Belgium

Status

Withdrawn

Address

AZ Delta (Stedelijk Ziekenhuis)

Roeselare, , 8800

CHU Sart Tilman; Tour de Pathologie, Liège, Belgium

Status

Recruiting

Address

CHU Sart Tilman; Tour de Pathologie

Liège, , 4000

AZ Sint Elisabeth Herentals, Herentals, Belgium

Status

Recruiting

Address

AZ Sint Elisabeth Herentals

Herentals, , 2200

Universitair Ziekenhuis Gent; Oncology, Gent, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Gent; Oncology

Gent, , 9000

Bruxelles, Belgium

Status

Recruiting

Address

Cliniques Universitaires Saint-Luc; Pharmacy

Bruxelles, , 1200

Bruxelles, Belgium

Status

Recruiting

Address

Universitair Ziekenhuis Brussel; Neurology

Bruxelles, , 1090

CHU St Pierre (St Pierre), Brussels, Belgium

Status

Recruiting

Address

CHU St Pierre (St Pierre)

Brussels, , 1000

Imeldaziekenhuis, Bonheiden, Belgium

Status

Recruiting

Address

Imeldaziekenhuis

Bonheiden, , 2820

Sint-Vincentius Antwerpen, Antwerpen, Belgium

Status

Recruiting

Address

Sint-Vincentius Antwerpen

Antwerpen, , 2018

Privatklinik Doebling, Wien, Austria

Status

Withdrawn

Address

Privatklinik Doebling

Wien, , 1190

Medizinische Universität Wien, Wien, Austria

Status

Recruiting

Address

Medizinische Universität Wien

Wien, , 1090

Salzburg, Austria

Status

Recruiting

Address

LKH - Universitätsklinikum der PMU Salzburg

Salzburg, , 5020

KH der Barmherzigen Brüder Linz, Linz, Austria

Status

Terminated

Address

KH der Barmherzigen Brüder Linz

Linz, , 4040

Klagenfurt, Austria

Status

Recruiting

Address

Klinikum Klagenfurt am Wörtersee; Acute geriatric care

Klagenfurt, , 9020

Hue Central Hospital, Hue, Vietnam

Status

Withdrawn

Address

Hue Central Hospital

Hue, ,

People's Hospital 115, Ho Chi Minh City, Vietnam

Status

Withdrawn

Address

People's Hospital 115

Ho Chi Minh City, ,

E Hospital, Hanoi, Vietnam

Status

Withdrawn

Address

E Hospital

Hanoi, ,

103 Military Hospital, Hanoi, Vietnam

Status

Withdrawn

Address

103 Military Hospital

Hanoi, ,

Wishaw General Hospital, Wishaw, United Kingdom

Status

Withdrawn

Address

Wishaw General Hospital

Wishaw, , ML2 0DP

Torbay Hospital, Torquay, United Kingdom

Status

Withdrawn

Address

Torbay Hospital

Torquay, , TQ2 7AA

Southampton General Hospital, Southampton, United Kingdom

Status

Recruiting

Address

Southampton General Hospital

Southampton, , SO16 6YD

Salford Royal, Salford, United Kingdom

Status

Terminated

Address

Salford Royal

Salford, , M6 8HD

Nottingham, United Kingdom

Status

Completed

Address

Nottingham University Hospitals NHS Trust

Nottingham, , NG7 2UH

Norfolk and Norwich University Hospital, Norwich, United Kingdom

Status

Terminated

Address

Norfolk and Norwich University Hospital

Norwich, , NR4 7UY

Royal Victoria Infirmary, Newcastle upon Tyne, United Kingdom

Status

Recruiting

Address

Royal Victoria Infirmary

Newcastle upon Tyne, , NE1 4LP

Fairfield General Hospital, Manchester, United Kingdom

Status

Completed

Address

Fairfield General Hospital

Manchester, , M8 5RB

Chelsea & Westminster Hospital, London, United Kingdom

Status

Terminated

Address

Chelsea & Westminster Hospital

London, , SW10 9NH

King's College London, London, United Kingdom

Status

Recruiting

Address

King's College London

London, , SE5 9NU

St Thomas Hospital, London, United Kingdom

Status

Completed

Address

St Thomas Hospital

London, , SE1 7EH

Royal Free Hospital, London, United Kingdom

Status

Terminated

Address

Royal Free Hospital

London, , NW3 2QS

University College London Hospital, London, United Kingdom

Status

Recruiting

Address

University College London Hospital

London, , NW1 - 2PG

The Royal London Hospital, London, United Kingdom

Status

Completed

Address

The Royal London Hospital

London, , E1 1BB

Royal Liverpool University Hospital, Liverpool, United Kingdom

Status

Withdrawn

Address

Royal Liverpool University Hospital

Liverpool, , L7 8XP

St James University Hospital, Leeds, United Kingdom

Status

Recruiting

Address

St James University Hospital

Leeds, , LS9 7TF

St Mark's Hospital, Harrow, United Kingdom

Status

Withdrawn

Address

St Mark's Hospital

Harrow, , HA1 3UJ

Glasgow, United Kingdom

Status

Terminated

Address

Glasgow Royal Infirmary; Dept Of Gastroenterology 1

Glasgow, , G4 0SF

Exeter, United Kingdom

Status

Recruiting

Address

Royal Devon and Exeter Hospital (Wonford)

Exeter, , EX2 5DW

Western General Hospital, Edinburgh, United Kingdom

Status

Terminated

Address

Western General Hospital

Edinburgh, , EH4 2XU

University Hospital of North Durham, Durham, United Kingdom

Status

Terminated

Address

University Hospital of North Durham

Durham, , DH15TW

Ninewells Hospital, Dundee, United Kingdom

Status

Withdrawn

Address

Ninewells Hospital

Dundee, , DD12 9SY

Isar Klinik GmbH, München, Germany

Status

Recruiting

Address

Isar Klinik GmbH

München, , 80331

Universitaetsklinikum Muenster, Muenster, Germany

Status

Recruiting

Address

Universitaetsklinikum Muenster

Muenster, , 48149

Universitaetsklinikum Muenster; Urology, Muenster, Germany

Status

Recruiting

Address

Universitaetsklinikum Muenster; Urology

Muenster, , 48149

Gastroenterologische Praxis Minden, Minden, Germany

Status

Terminated

Address

Gastroenterologische Praxis Minden

Minden, , 32423

Mannheim, Germany

Status

Recruiting

Address

Klinikum Mannheim GmbH Universitätsklinikum

Mannheim, , 68167

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