MedPath

A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease

Phase 3
Completed
Conditions
Colitis, Ulcerative
Crohn's Disease
Interventions
Registration Number
NCT02620046
Lead Sponsor
Takeda
Brief Summary

The main aim of the study is to check for long-term side effects of Vedolizumab Subcutaneous (also known as Vedolizumab SC) in people with ulcerative colitis and Crohn's disease. Vedolizumab SC will be given as an injection just under the skin. This type of injection is called a subcutaneous injection or SC for short. Another aim of the study is to collect information on whether the participant's condition remains under control or improves during and after treatment with Vedolizumab SC.

Participants who previously took part in studies MLN0002SC-3027 or MLN0002SC-3031 will be invited to visit the study clinic. At this visit, the study doctor will check if each participant can take part in this study.

For those who can take part, participants will receive a subcutaneous injection of vedolizumab SC either once a week or once every 2 weeks. How often each participant receives vedolizumab SC will depend on their results from the previous study and on how active their condition is. Participants might be able to self-inject vedolizumab SC after being trained by the study doctors. During this study, the dose of vedolizumab SC might be increased for participants whose condition worsens.

Participants will continue treatment with vedolizumab SC until it is approved in their particular country, the participant decides to stop treatment, or the sponsor stops the study. If the sponsor stops the study before vedolizumab SC is approved in all countries, the sponsor will make sure all affected participants will have access to vedolizumab SC outside of the study.

After their final dose of vedolizumab SC, participants will visit the clinic 18 weeks later for a final check-up. Then, the clinic will telephone the participants 6 months after their final dose of vedolizumab SC to check if they have any health problems.

Detailed Description

The drug being tested in this study is called vedolizumab subcutaneous (vedolizumab SC). Vedolizumab SC is being tested to assess its long-term safety and effectiveness in treating participants with UC or CD. This study will look at the long-term side effects and response/remission of UC and CD in participants who received vedolizumab SC in a prior vedolizumab SC study.

The study will enroll up to 692 patients. All participants enrolled in this study will have previously participated in the MLN0002SC-3027 or MLN0002SC-3031 study. Participants who completed the Maintenance Period (Week 52) in their previous study, or who did not achieve a clinical response at Week 6 but who did achieve a clinical response at Week 14 after having received a third vedolizumab IV infusion at Week 6 in their previous study, will receive open-label vedolizumab SC 108 mg, once every 2 weeks (Q2W). Participants who withdrew early from the Maintenance Period of their previous study due to disease worsening or need for rescue medications will receive open-label vedolizumab SC 108 mg, once every week (QW). Participants receiving SC 108 mg Q2W who experience treatment failure (disease worsening or need for rescue medications while in the current study will be dose escalated to vedolizumab SC 108 mg QW.

This multi-center trial will be conducted worldwide. Participation in this vedolizumab SC study will continue until vedolizumab SC becomes commercially available, the participant withdraws from the study, or the sponsor decides to close the study. Participants will make multiple visits to the clinic, plus a final visit 18 weeks after last dose of study drug for a follow-up assessment. Participants will also participate in a long-term safety follow-up, by phone, at 6 months after the last dose of study drug.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
746
Inclusion Criteria
  1. Prior participation in Study MLN0002SC-3027 or MLN0002SC-3031, and, in the opinion of the investigator, tolerated the study drug well. Early withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 must have been due to treatment failure during the Maintenance Period.
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Exclusion Criteria
  1. Surgical intervention for IBD during or after participation in Study MLN0002SC-3027 or MLN0002SC-3031, or at any time during this study.
  2. Chronic or severe infection, or, any new, unstable, or uncontrolled cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, neurologic, oncologic, or other medical disorder developed during or after participation in a prior vedolizumab study that, in the opinion of the investigator, would confound the study results or compromise participant safety.
  3. Withdrawal from Study MLN0002SC-3027 or MLN0002SC-3031 due to a study-drug related adverse event (AE).
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group A: Vedolizumab SC 108 mg Q2WVedolizumab SCParticipants from studies MLN0002SC-3027 and MLN0002SC-3031 who: * Completed the Maintenance Period (Week 52), or * Were not randomized into Maintenance Period and achieved response at Week 14 after having received a third vedolizumab IV infusion at Week 6.
Group B: Vedolizumab SC 108 mg QWVedolizumab SCParticipants from studies MLN0002SC-3027 and MLN0002SC-3031 who withdrew early from the Maintenance Period due to treatment failure. •Participants from current study who experience treatment failure while on study.
Primary Outcome Measures
NameTimeMethod
Number of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab TreatmentFrom start of study medication through 18 weeks after the last dose

Number of TEAEs and SAEs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of TEAEs and SAEs per 100-participant-years.

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants with Ulcerative Colitis Achieving Clinical RemissionFrom Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, up to 7 years

Clinical remission is defined as a partial Mayo score of ≤ 2 with no individual subscore \>1.

Number of Adverse Events of Special Interest (AESIs) Adjusted by Duration of Participant's Exposure to Long-term Vedolizumab TreatmentFrom start of study medication through 18 weeks after the last dose

Number of AESIs adjusted by duration of exposure to study treatment scaled such that it provides an incidence rate of AESIs per 100-participant-years. AESIs include hypersensitivity reactions (including injections site reactions), serious infections, malignancies, hepatotoxicity (abnormal liver function test) and progressive multifocal leukoencephalopathy (PML).

Percentage of Participants with Crohn's Disease Achieving Clinical ResponseFrom Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years

Clinical response is defined as a decrease in HBI score of ≥3 points from baseline in CD participants (randomized early terminator CD participants only \[defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52\]).

Percentage of Participants with Crohn's Disease (CD) Achieving Clinical RemissionFrom Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years

Clinical remission is defined as total HBI score of ≤4 points in CD participants only (defined as randomized CD participants withdrawn from the parent study between Week 6 and Week 52).

Percentage of Participants with Ulcerative Colitis Achieving Partial Mayo Scoring Clinical ResponseFrom Week 0 (Day 1) up to availability of vedolizumab SC, withdrawal by participant, or study closure, Up to 7 years

Clinical response is defined as a decrease in the partial Mayo Score of at least 2 points and ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point from baseline or absolute rectal bleeding subscore of ≤1 point.

Trial Locations

Locations (301)

AZ Groeninge - Kennedylaan

🇧🇪

Kortrijk, Belgium

L & L Research Choices, Inc.

🇺🇸

Miami, Florida, United States

Hospital Sao Vicente de Paulo

🇧🇷

Passo Fundo, Rio Grande Do Sul, Brazil

St John of God Subiaco Hospital

🇦🇺

Subiaco, Western Australia, Australia

Hospital de Clinicas de Porto Alegre

🇧🇷

Porto Alegre, Rio Grande Do Sul, Brazil

Morales Vargas Centro de Investigacion, S.C.

🇲🇽

Leon, Guanajuato, Mexico

Centro de Investigacion Farmacologica del Bajio, S.C.

🇲🇽

Leon, Guanajuato, Mexico

Fiona Stanley Hospital

🇦🇺

Murdoch, Western Australia, Australia

West Tallinn Central Hospital

🇪🇪

Tallinn, Estonia

Pest Megyei Flor Ferenc Korhaz

🇭🇺

Kistarcsa, Hungary

MHAT - Silistra AD

🇧🇬

Silistra, Bulgaria

"City Clinic UMHAC" EOOD

🇧🇬

Sofia, Bulgaria

UMHAT 'Sveta Anna' AD

🇧🇬

Sofia, Bulgaria

MC "Tsaritsa Yoanna' EOOD

🇧🇬

Sliven, Bulgaria

Karolina Korhaz-Rendelointezet

🇭🇺

Mosonmagyarovar, Hungary

MHAT "Hadzhi Dimitar", OOD

🇧🇬

Sliven, Bulgaria

Clinical Center of Serbia

🇷🇸

Belgrade, Serbia

Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak

🇭🇺

Budapest, Hungary

Fourth MHAT - Sofia EAD

🇧🇬

Sofia, Bulgaria

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktatokorhaz

🇭🇺

Miskolc, Hungary

University Clinical Hospital Mostar

🇧🇦

Mostar, Bosnia and Herzegovina

Pannonia Maganorvosi Centrum

🇭🇺

Budapest, Hungary

Institutul Clinic Fundeni

🇷🇴

Bucuresti, Romania

S.C Centrul de Gastroenterologie Dr. Goldis S.R.L

🇷🇴

Timisoara, Romania

Tri-Service General Hospital

🇨🇳

Taipei, Taiwan

Dr MJ Prins Practice

🇿🇦

Cape Town, Western Cape, South Africa

Universidad Autonoma de Nuevo Leon, Hospital Universitario Dr. Jose Eleuterio Gonzalez

🇲🇽

Monterrey, Nuevo Leon, Mexico

Twoja Przychodnia-Szczecinskie Centrum Medyczne

🇵🇱

Szczecin, Poland

Mackay Memorial Hospital

🇨🇳

Taipei, Taiwan

Vilnius University Hospital Santariskiu Clinics, Public Institution

🇱🇹

Vilnius, Lithuania

Clinical Helth Centre Zvezdara

🇷🇸

Belgrade, Serbia

Clinical Center Nis

🇷🇸

Nis, Serbia

iBiomed Guadalajara

🇲🇽

Zapopan, Jalisco, Mexico

Univerzitna nemocnica Bratislava, Nemocnica Ruzinov

🇸🇰

Bratislava, Slovakia

KM Management spol. s r.o.

🇸🇰

Nitra, Slovakia

Arizona Arthritis & Rheumatology Research, PLLC

🇺🇸

Phoenix, Arizona, United States

Regionshospitalet Silkeborg

🇩🇰

Silkeborg, Denmark

LHSC - University Hospital

🇨🇦

London, Ontario, Canada

Shaare Zedek Medical Center

🇮🇱

Jerusalem, Israel

Gastroenterology Associates, LLC

🇺🇸

Baton Rouge, Louisiana, United States

Research Concierge, LLC

🇺🇸

Owensboro, Kentucky, United States

Shafran Gastroenterology Center

🇺🇸

Winter Park, Florida, United States

Carle Foundation Hospital

🇺🇸

Urbana, Illinois, United States

Nature Coast Clinical Research, LLC

🇺🇸

Inverness, Florida, United States

Gastroenterology Group of Naples

🇺🇸

Naples, Florida, United States

Cotton-O'Neil Clinical Research Center, Digestive Health

🇺🇸

Topeka, Kansas, United States

Ehrhardt Clinical Research, LLC

🇺🇸

Belton, Missouri, United States

Mayo Clinic - Rochester

🇺🇸

Rochester, Minnesota, United States

Hospital Italiano

🇦🇷

Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina

Allegiance Research Specialists, LLC

🇺🇸

Milwaukee, Wisconsin, United States

Mater Hospital Brisbane

🇦🇺

South Brisbane, Queensland, Australia

Royal Adelaide Hospital

🇦🇺

Adelaide, South Australia, Australia

Monash Medical Centre Clayton

🇦🇺

Bentleigh East, Victoria, Australia

PerCuro Clinical Research Ltd.

🇨🇦

Victoria, British Columbia, Canada

Nemocnice Tabor a.s.

🇨🇿

Tabor, Czechia

North Estonia Medical Centre Foundation

🇪🇪

Tallinn, Estonia

Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

🇭🇺

Szekesfehervar, Hungary

HaEmek Medical Center

🇮🇱

Afula, Israel

Barzilai Medical Center

🇮🇱

Ashkelon, Israel

Tel Aviv Sourasky Medical Center

🇮🇱

Tel Aviv, Israel

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

🇮🇹

San Donato Milanese, Milano, Italy

Azienda Ospedaliera Ospedale Cannizzaro

🇮🇹

Catania, Italy

IRCCS Ospedale Casa Sollievo della Sofferenza

🇮🇹

San Giovanni Rotondo, Foggia, Italy

Azienda Socio Sanitaria Territoriale Fatebenefratelli (Presidio Ospedale Sacco)

🇮🇹

Milano, Italy

Azienda Ospedaliera Universitaria Policlinico G. Martino

🇮🇹

Messina, Italy

Azienda Ospedaliera di Padova

🇮🇹

Padova, Italy

Azienda Ospedaliera Vincenzo Cervello

🇮🇹

Palermo, Italy

Policlinico Universitario Agostino Gemelli

🇮🇹

Roma, Italy

Hiroshima University Hospital

🇯🇵

Hiroshima-shi, Hiroshima-Ken, Japan

Yokoyama IBD Clinic

🇯🇵

Nagoya-shi, Aichi-Ken, Japan

Fukuoka University Hospital

🇯🇵

Fukuoka-shi, Fukuoka-Ken, Japan

Tokushukai Sapporo Tokushukai Hospital

🇯🇵

Sapporo-shi, Hokkaido, Japan

Tokushukai Sapporo Higashi Tokushukai Hospital

🇯🇵

Sapporo-shi, Hokkaido, Japan

Hyogo College of Medicine Hospital

🇯🇵

Nishinomiya-shi, Hyogo-Ken, Japan

Kagawa Prefectural Central Hospital

🇯🇵

Takamatsu-shi, Kagawa-Ken, Japan

Iwate Medical University Hospital

🇯🇵

Morioka-shi, Iwate-Ken, Japan

Gokeikai Ofuna Chuo Hospital

🇯🇵

Kamakura-shi, Kanagawa-Ken, Japan

Osaka City General Hospital

🇯🇵

Osaka-shi, Osaka-Fu, Japan

Shiga University of Medical Science Hospital

🇯🇵

Otsu-shi, Shiga-Ken, Japan

Hamamatsu South Hospital

🇯🇵

Hamamatsu-shi, Shizuoka-Ken, Japan

Saga University Hospital

🇯🇵

Saga-shi, Saga-Ken, Japan

Medical Hospital, Tokyo Medical and Dental University

🇯🇵

Bunkyo-ku, Tokyo-To, Japan

Kyorin University Hospital

🇯🇵

Mitaka-shi, Tokyo-To, Japan

Jikei University Hospital

🇯🇵

Minato-ku, Tokyo-To, Japan

JCHO Tokyo Yamate Medical Center

🇯🇵

Shinjuku-ku, Tokyo-To, Japan

Keio University Hospital

🇯🇵

Shinjuku-ku, Tokyo-To, Japan

Wakayama Medical University Hospital

🇯🇵

Wakayama-shi, Wakayama-Ken, Japan

Yeungnam University Hospital

🇰🇷

Daegu, Korea, Republic of

Kyungpook National University Hospital

🇰🇷

Daegu, Gyeongsangbuk-do, Korea, Republic of

Kyung Hee University Hospital

🇰🇷

Seoul, Korea, Republic of

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

Severance Hospital, Yonsei University

🇰🇷

Seoul, Korea, Republic of

Kangbuk Samsung Hospital

🇰🇷

Seoul, Korea, Republic of

Samsung Medical Center

🇰🇷

Seoul, Korea, Republic of

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

🇱🇹

Kaunas, Lithuania

Klaipeda Republican Hospital, Public Institution

🇱🇹

Klaipeda, Lithuania

Asan Medical Center

🇰🇷

Seoul, Korea, Republic of

Klaipeda University Hospital, Public Institution

🇱🇹

Klaipeda, Lithuania

Christus Muguerza Sur S.A. de C.V.

🇲🇽

Monterrey, Nuevo Leon, Mexico

Academisch Medisch Centrum

🇳🇱

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen (UMCG)

🇳🇱

Groningen, Netherlands

Albert Schweitzer Ziekenhuis

🇳🇱

Dordrecht, Netherlands

Erasmus Medisch Centrum

🇳🇱

Rotterdam, Netherlands

Maastricht University Medical Center

🇳🇱

Maastricht, Netherlands

SPZOZ Uniwersytecki Szpital Klin. nr 1 im.N.Barlickiego UM

🇵🇱

Lodz, Poland

GASTROMED Sp. z o.o.

🇵🇱

Lublin, Poland

NZOZ Vitamed

🇵🇱

Bydgoszcz, Poland

SP ZOZ Wojewodzki Szpital Zespolony im. J. Sniadeckiego

🇵🇱

Bialystok, Poland

Gabinet Endoskopii Przewodu Pokarmowego

🇵🇱

Krakow, Poland

Santa Familia Centrum Badan, Profilaktyki i Leczenia

🇵🇱

Lodz, Poland

Centrum Zdrowia MDM

🇵🇱

Warszawa, Poland

Centralny Szpital Kliniczny MSW w Warszawie

🇵🇱

Warszawa, Poland

Centrum Onkologii-Instytut im. M. Sklodowskiej Curie

🇵🇱

Warszawa, Poland

Nzoz Vivamed

🇵🇱

Warszawa, Poland

LexMedica Osrodek Badan Klinicznych

🇵🇱

Wroclaw, Poland

Ars-Medica S.C Rybak Maria, Rybak Zbigniew

🇵🇱

Wroclaw, Poland

Spitalul Clinic Colentina

🇷🇴

Bucuresti, Romania

TSBIH "Territorial Clinical Hospital"

🇷🇺

Krasnoyarsk, Russian Federation

BHI of Omsk region "Clinical Oncology Dispensary"

🇷🇺

Omsk, Russian Federation

SBEI HPE "Rostov State Medical University" of the MoH of the RF

🇷🇺

Rostov-on-Don, Russian Federation

CI of Kyiv RC Kyiv Regional Clinical Hospital

🇺🇦

Kyiv, Ukraine

LLC "RIAT SPb"

🇷🇺

Saint-Petersburg, Russian Federation

Military Medical Academy

🇷🇸

Belgrade, Serbia

Clinical Center Bezanijska Kosa

🇷🇸

Belgrade, Serbia

Clinical Center Zemun

🇷🇸

Belgrade, Serbia

Clinical Center Kragujevac

🇷🇸

Kragujevac, Serbia

Gastro I, s.r.o.

🇸🇰

Presov, Slovakia

Gastroped s.r.o.

🇸🇰

Kosice, Slovakia

Fakultna nemocnica s poliklinikou F.D. Roosevelta

🇸🇰

Banska Bystrica, Slovakia

Dr CCM Ziady Practice

🇿🇦

Pretoria, Gauteng, South Africa

Hospital Universitari Germans Trias i Pujol

🇪🇸

Badalona, Barcelona, Spain

Hospital General Universitario de Alicante

🇪🇸

Alicante, Spain

Danderyds Sjukhus

🇸🇪

Stockholm, Sweden

Hospital Universitario Ramon y Cajal

🇪🇸

Madrid, Spain

Hospital Universitari de Girona Dr Josep Trueta

🇪🇸

Girona, Spain

Complejo Hospitalario de Pontevedra

🇪🇸

Pontevedra, Spain

Karolinska Universitetssjukhuset - Solna

🇸🇪

Stockholm, Sweden

National Taiwan University Hospital

🇨🇳

Taipei, Taiwan

Ankara University Medical Faculty

🇹🇷

Ankara, Turkey

Gazi University Medical Faculty

🇹🇷

Ankara, Turkey

Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty

🇹🇷

Istanbul, Turkey

Marmara University Pendik Research and Training Hospital

🇹🇷

Istanbul, Turkey

Kocaeli Derince Training and Research Hospital

🇹🇷

Kocaeli, Turkey

Mersin University Medical Faculty

🇹🇷

Mersin, Turkey

RCNECRCH Dept of Surgery, SHEI Ukr BSMU

🇺🇦

Chernivtsi, Ukraine

SI Institute of Gastroenterology of NAMSU Dept of Stomach & Duodenum Diseases, D&ThN SI DMA of MoHU

🇺🇦

Dnipro, Ukraine

Regional CH Dep of Gastroenterology SHEI Ivano-Frankivsk NMU

🇺🇦

Ivano-Frankivsk, Ukraine

MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE

🇺🇦

Kyiv, Ukraine

CNE Prof. O.O. Shalimov Kharkiv City Clinical Hospital #2 of KCC

🇺🇦

Kharkiv, Ukraine

CI A.and O. Tropiny City Clinical Hospital

🇺🇦

Kherson, Ukraine

Kyiv CCH #12 Dept of Therapy O.O.Bogomolets NMU

🇺🇦

Kyiv, Ukraine

Communal City Clinical Hospital of Ambulance, Dept of Therapy #1 D.Halytskyi Lviv NMU

🇺🇦

Lviv, Ukraine

CI Odesa Regional Clinical Hospital

🇺🇦

Odesa, Ukraine

Private Small Enterprise Medical Center Pulse

🇺🇦

Vinnytsia, Ukraine

Ternopil University Hospital

🇺🇦

Ternopil, Ukraine

Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU

🇺🇦

Vinnytsia, Ukraine

Royal Devon and Exeter Hospital (Wonford)

🇬🇧

Exeter, Devon, United Kingdom

CI City Hospital #1

🇺🇦

Zaporizhzhia, Ukraine

St George's Hospital

🇬🇧

London, Greater London, United Kingdom

University Hospital Coventry

🇬🇧

Coventry, West Midlands, United Kingdom

Kinshukai Infusion Clinic

🇯🇵

Osaka-shi, Osaka-Fu, Japan

Hospital Universitario Puerta de Hierro Majadahonda

🇪🇸

Majadahonda, Madrid, Spain

Kitasato University Kitasato Institute Hospital

🇯🇵

Minato-ku, Tokyo-To, Japan

Arkansas Primary Care Clinic, PA

🇺🇸

Little Rock, Arkansas, United States

Rocky Mountain Clinical Research, LLC

🇺🇸

Wheat Ridge, Colorado, United States

Medical Research Center of Connecticut, LLC

🇺🇸

Hamden, Connecticut, United States

Middlesex Gastroenterology Associates

🇺🇸

Middletown, Connecticut, United States

Florida Center for Gastroenterology

🇺🇸

Largo, Florida, United States

BRCR Medical Center, Inc.

🇺🇸

Pembroke Pines, Florida, United States

Atlanta Gastroenterology Associates

🇺🇸

Atlanta, Georgia, United States

Florida Medical Clinic, P.A.

🇺🇸

Zephyrhills, Florida, United States

Gastroenterology Associates of Central Georgia

🇺🇸

Macon, Georgia, United States

Rush University Medical Center

🇺🇸

Chicago, Illinois, United States

Grand Teton Research Group, PLL

🇺🇸

Idaho Falls, Idaho, United States

Tri-State Gastroenterology Associates

🇺🇸

Crestview Hills, Kentucky, United States

Lafayette General Medical Center

🇺🇸

Lafayette, Louisiana, United States

Louisiana Research Center, LLC

🇺🇸

Shreveport, Louisiana, United States

Metropolitan Gastroenterology Group, PC, Chevy Chase Clinical Research

🇺🇸

Chevy Chase, Maryland, United States

Gastroenterology Associates of Western Michigan, P.L.C.

🇺🇸

Wyoming, Michigan, United States

Clinical Research Institute of Michigan, LLC

🇺🇸

Chesterfield, Michigan, United States

Digestive Health Center PA

🇺🇸

Ocean Springs, Mississippi, United States

Huron Gastroenterology Associates

🇺🇸

Ypsilanti, Michigan, United States

Long Island Clinical Research Associates

🇺🇸

Great Neck, New York, United States

AGA Clinical Research Associates, LLC

🇺🇸

Egg Harbor Township, New Jersey, United States

Premier Medical Group of the Hudson Valley, PC

🇺🇸

Poughkeepsie, New York, United States

Dayton Gastroenterology, Inc

🇺🇸

Dayton, Ohio, United States

Gastro-Enterology Research of Lima

🇺🇸

Lima, Ohio, United States

Main Line Gastroenterology Associates

🇺🇸

Perkasie, Pennsylvania, United States

Gastroenterology Center of the MidSouth PC

🇺🇸

Germantown, Tennessee, United States

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

San Antonio Gastroenterology

🇺🇸

San Antonio, Texas, United States

Tyler Research Institute, LLC

🇺🇸

Tyler, Texas, United States

Gastroenterology Associates of Tidewater

🇺🇸

Chesapeake, Virginia, United States

Virginia Mason Seattle Main Clinic

🇺🇸

Seattle, Washington, United States

Centro Medico Viamonte SRL

🇦🇷

Ciudad Autonoma de Buenos Aires, Ciudad Autonoma Buenos Aires, Argentina

Centro de Investigaciones Medicas Mar del Plata

🇦🇷

Mar del Plata, Buenos Aires, Argentina

Concord Repatriation General Hospital

🇦🇺

Concord, New South Wales, Australia

Nepean Hospital

🇦🇺

Kingswood, New South Wales, Australia

Tennyson Centre Day Hospital

🇦🇺

Kurralta Park, South Australia, Australia

Princess Alexandra Hospital

🇦🇺

Woolloongabba, Queensland, Australia

Ballarat Base Hospital

🇦🇺

Ballarat, Victoria, Australia

St Vincent's Hospital Melbourne

🇦🇺

Fitzroy, Victoria, Australia

St Frances Xavier Cabrini Hospital

🇦🇺

Malvern, Victoria, Australia

Royal Melbourne Hospital

🇦🇺

Melbourne, Victoria, Australia

Imeldaziekenhuis

🇧🇪

Bonheiden, Belgium

The Alfred Hospital

🇦🇺

Melbourne, Victoria, Australia

AZ Sint-Lucas

🇧🇪

Brugge, Belgium

ZNA Jan Palfijn

🇧🇪

Merksem, Belgium

Universitair Ziekenhuis Gent

🇧🇪

Gent, Belgium

University Clinical Centre of the Republic of Srpska

🇧🇦

Banja Luka, Bosnia and Herzegovina

Clinique Saint-Pierre

🇧🇪

Ottignies, Belgium

AZ Delta

🇧🇪

Roeselare, Belgium

Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda

🇧🇷

Goiania, Goias, Brazil

HUGG - Hospital Universitario Gaffree e Guinle

🇧🇷

Rio de Janeiro, Rio Do Janeiro, Brazil

HUCFF-UFRJ - Hospital Universitario Clementino Fraga Filho - Universidade Federal do Rio de Janeiro

🇧🇷

Rio de Janeiro, Rio Do Janeiro, Brazil

Faculdade de Medicina do ABC

🇧🇷

Santo Andre, Sao Paulo, Brazil

UNESP - Faculdade de Medicina da Universidade Estadual Paulista - Campus Botucatu

🇧🇷

Botucatu, Sao Paulo, Brazil

Options Health Research

🇺🇸

Tulsa, Oklahoma, United States

Atlanta Gastroenterology Specialists, PC

🇺🇸

Suwanee, Georgia, United States

Irmandade da Santa Casa da Misericordia de Santos

🇧🇷

Santos, Sao Paulo, Brazil

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto

🇧🇷

Sao Jose do Rio Preto, Sao Paulo, Brazil

"MHAT Avis - Medica" OOD

🇧🇬

Pleven, Bulgaria

UMHAT 'Dr. Georgi Stranski', EAD

🇧🇬

Pleven, Bulgaria

Second MHAT - Sofia AD

🇧🇬

Sofia, Bulgaria

Medical Center "Excelsior", OOD

🇧🇬

Sofia, Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

🇧🇬

Sofia, Bulgaria

UMHAT 'Tsaritsa Yoanna - ISUL', EAD

🇧🇬

Sofia, Bulgaria

Military Medical Academy - MHAT - Sofia

🇧🇬

Sofia, Bulgaria

Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

🇧🇬

Stara Zagora, Bulgaria

Zeidler Ledcor Centre - University of Alberta

🇨🇦

Edmonton, Alberta, Canada

LHSC - Victoria Hospital

🇨🇦

London, Ontario, Canada

Clinical Hospital Centre Rijeka

🇭🇷

Rijeka, Croatia

Toronto Digestive Disease Associates, Inc.

🇨🇦

Vaughan, Ontario, Canada

Clinical Hospital Centre Osijek

🇭🇷

Osijek, Croatia

Special Hospital Medico

🇭🇷

Rijeka, Croatia

University hospital centre Zagreb

🇭🇷

Zagreb, Croatia

Clinical Hospital Dubrava

🇭🇷

Zagreb, Croatia

CCBR - Czech Brno, s.r.o..

🇨🇿

Brno, Czechia

Hepato-Gastroenterologie HK s.r.o.

🇨🇿

Hradec Kralove, Czechia

A-SHINE s.r.o.

🇨🇿

Plzen, Czechia

CLINTRIAL s.r.o.

🇨🇿

Praha 10, Czechia

Odense Universitetshospital

🇩🇰

Odense C, Denmark

Axon Clinical s.r.o.

🇨🇿

Praha 5, Czechia

CCBR Czech Prague, s.r.o.

🇨🇿

Praha 3, Czechia

Tartu University Hospital

🇪🇪

Tartu, Estonia

LMU - Campus Grosshadern

🇩🇪

Muenchen, Bayern, Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

🇩🇪

Frankfurt, Hessen, Germany

Universitaetsklinikum Koeln

🇩🇪

Koeln, Nordrhein Westfalen, Germany

Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz

🇩🇪

Mainz, Rheinland Pfalz, Germany

Universitaetsklinikum Magdeburg A.oe.R

🇩🇪

Magdeburg, Sachsen Anhalt, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Kiel

🇩🇪

Kiel, Schleswig Holstein, Germany

Medizinische Hochschule Hannover

🇩🇪

Hannover, Niedersachsen, Germany

EUGASTRO GmbH

🇩🇪

Leipzig, Sachsen, Germany

Universitaetsklinikum Schleswig-Holstein - Campus Luebeck

🇩🇪

Lubeck, Schleswig Holstein, Germany

Charite - Campus Virchow-Klinikum

🇩🇪

Berlin, Germany

DRK Kliniken Berlin Westend

🇩🇪

Berlin, Germany

Krankenhaus Waldfriede e. V.

🇩🇪

Berlin, Germany

Obudai Egeszsegugyi Centrum Kft.

🇭🇺

Budapest, Hungary

Markhot Ferenc Oktatokorhaz es Rendelointezet

🇭🇺

Eger, Hungary

Semmelweis Egyetem

🇭🇺

Budapest, Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza

🇭🇺

Gyula, Hungary

Tolna Megyei Balassa Janos Korhaz

🇭🇺

Szekszard, Hungary

Soroka University Medical Center

🇮🇱

Beer Sheva, Israel

Rambam Health Care Campus

🇮🇱

Haifa, Israel

Pecsi Tudomanyegyetem

🇭🇺

Pecs, Hungary

Wolfson Medical Center

🇮🇱

Holon, Israel

Kaplan Medical Center

🇮🇱

Rechovot, Israel

Galilee Medical Center

🇮🇱

Nahariya, Israel

Chaim Sheba Medical Center

🇮🇱

Ramat Gan, Israel

Istituto Clinico Humanitas

🇮🇹

Rozzano, Milano, Italy

A.O.U. Policlinico di Modena

🇮🇹

Modena, Italy

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

🇮🇹

Bologna, Italy

Azienda Ospedaliera Universitaria "Federico II"

🇮🇹

Napoli, Italy

Azienda Ospedaliera San Camillo Forlanini

🇮🇹

Roma, Italy

Ehime Prefectural Central Hospital

🇯🇵

Matsuyama-shi, Ehime-Ken, Japan

Fukuoka University Chikushi Hospital

🇯🇵

Chikushino-shi, Fukuoka-Ken, Japan

Toho University Sakura Medical Center

🇯🇵

Sakura-shi, Chiba-Ken, Japan

Sapporo-Kosei General Hospital

🇯🇵

Sapporo-shi, Hokkaido, Japan

Kurume University Hospital

🇯🇵

Kurume-shi, Fukuoka-Ken, Japan

Okayama University Hospital

🇯🇵

Okayama-shi, Okayama-Ken, Japan

Sociedad de Metabolismo y Corazon S.C

🇲🇽

Veracruz, Mexico

Instituto de Investigaciones Aplicadas a la Neurociencia A.C.

🇲🇽

Durango, Mexico

SP CSK im. prof. K. Gibinskiego SUM

🇵🇱

Katowice, Poland

LLC "Novosibirsk GastroCenter"

🇷🇺

Novosibirsk, Russian Federation

Kazan State Medical University

🇷🇺

Kazan, Russian Federation

FSBIH "Central Clinical Hospital of Russian Academy of Sciences"

🇷🇺

Moscow, Russian Federation

SBEIHPE Novosibirsk State Medical University

🇷🇺

Novosibirsk, Russian Federation

SPb SBIH "City Hospital of Saint Martyr Elizaveta"

🇷🇺

St. Petersburg, Russian Federation

SPb SBIH "City Hospital # 40 of Kurortnyi region"

🇷🇺

Sestroretsk, Russian Federation

Clinical Center of Vojvodina

🇷🇸

Novi Sad, Serbia

Dr JP Wright Practice

🇿🇦

Cape Town, Western Cape, South Africa

Haydarpasa Numune Training and Research Hospital

🇹🇷

Istanbul, Turkey

Acibadem Fulya Hospital

🇹🇷

Istanbul, Turkey

Norfolk and Norwich University Hospital

🇬🇧

Norwich, Norfolk, United Kingdom

MCIC MC LLC Health Clinic

🇺🇦

Vinnytsia, Ukraine

Royal Free Hospital

🇬🇧

London, Greater London, United Kingdom

Whipps Cross University Hospital

🇬🇧

London, Greater London, United Kingdom

Royal Shrewsbury Hospital

🇬🇧

Shrewsbury, Shropshire, United Kingdom

Royal Wolverhampton hospital

🇬🇧

Wolverhampton, West Midlands, United Kingdom

Medical University of South Carolina (MUSC)

🇺🇸

Charleston, South Carolina, United States

University of North Carolina at Chapel Hill

🇺🇸

Chapel Hill, North Carolina, United States

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