A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)

Study Purpose

Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe Crohn's disease will be treated with vedolizumab. The main aim of the study is to check if participants achieve remission after treatment with the vedolizumab. Remission means symptoms improve or disappear and an endoscopy shows no signs of inflammation. Participants will receive 3 infusions of vedolizumab over 6 weeks. Then, those who have a clinical response will receive either a high dose or low dose of vedolizumab once every 8 weeks. They will receive the same dose every time.

Recruitment Criteria

Accepts Healthy Volunteers

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

No
Study Type

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.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. The participants has moderately to severely active CD, unresponsive or intolerant to their current standard of care (SOC). 2. The participants weigh ≥10 kg at the time of screening and enrollment into the study. 3. Participants with moderately to severely active Crohn's disease (CD) diagnosed at least 1 month before screening, defined by a Pediatric Crohn's Disease Activity Index (PCDAI) >30 and an simple endoscopic score for Crohn's Disease (SES-CD) >6 (or an SES-CD ≥4 if disease is confined to terminal ileum). 4. Participants who have failed, lost response to, or been intolerant to treatment with at least 1 of the following agents: corticosteroids, immunomodulators (eg, azathioprine (AZA), 6-mercaptopurine (6-MP), methotrexate [MTX]), and/or tumor necrosis factor (TNF)-α antagonist therapy (eg, infliximab, adalimumab). This includes participants who are dependent on corticosteroids or exclusive or partial enteral nutrition to control symptoms and who are experiencing worsening of disease in the moderate-to-severe range when attempting to wean off corticosteroids or discontinue exclusive enteral nutrition. 5. Participants with extensive colitis or pancolitis of >8 years' duration or left-sided colitis of >12 years' duration must have documented evidence of a negative surveillance colonoscopy within 12 months before screening. 6. Participants with vaccinations that are up-to-date based on the countrywide accepted schedule of childhood vaccines.

Exclusion Criteria:

1. Participants who have received either
  • (1) an investigational biologic (other than those listed in Exclusion Criterion #1) within 60 days or 5 half-lives before screening (whichever is longer); or (2) an approved biologic or biosimilar agent within 2 weeks before the first dose of study drug or at any time during the screening period.
2. Participants with active cerebral/meningeal disease, signs/symptoms or history of progressive multifocal leukoencephalopathy (PML) or any other major neurological disorders including stroke, multiple sclerosis, brain tumor or neurodegenerative disease. 3. The participants had a clinically significant infection (eg, pneumonia, pyelonephritis, coronavirus disease 2019 [COVID-19]) within 30 days prior to first dose of study drug. 4. The participants has received any live vaccinations within 30 days prior to first dose. 5. Participants who currently require surgical intervention or are anticipated to require surgical intervention for CD during this study. 6. Participants who have had subtotal or total colectomy or have a jejunostomy, ileostomy, colostomy, ileo-anal pouch, known fixed stenosis of the intestine, short bowel syndrome, or >3 small intestine resections. 7. Participants with a current diagnosis of indeterminate colitis. 8. Participants with clinical features suggesting monogenic very early-onset inflammatory bowel disease. 9. Active or latent tuberculosis (TB), as evidenced by a diagnostic TB test performed within 30 days of screening or during the screening Period that is positive, defined as:
  • - Positive QuantiFERON test or 2 successive indeterminate QuantiFERON tests, OR.
  • - A TB skin test reaction ≥5 mm.
10. The participants has chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection. 11. The participants has any identified congenital or acquired immunodeficiency (eg, common variable immunodeficiency, human immunodeficiency virus [HIV] infection, organ transplantation). 12. The participant has evidence of dysplasia or history of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix. 13. Participants with positive stool studies for ova and/or parasites or stool culture at screening visit. 14. Participants with positive Clostridium difficile stool test at screening visit.

Trial Details

Trial ID:

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.

NCT04779320
Phase

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 3
Lead Sponsor

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

Takeda
Principal Investigator

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

N/A
Principal Investigator Affiliation N/A
Agency Class

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

Industry
Overall Status Recruiting
Countries Australia, Belgium, Canada, China, Croatia, Czechia, Greece, Hungary, Israel, Italy, Japan, Korea, Republic of, Lithuania, Poland, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom, United States
Conditions

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

Crohn's Disease (CD)
Study Website: View Trial Website
Additional Details

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat pediatric participants who have moderately to severely active CD. The drug is tested and approved in adults in approximately 70 countries. Participants to be enrolled must have failed response to, lost response to, or been intolerant to at least 1 of the current standard of care (SOC) induction and maintenance therapies for CD including exclusive and/or partial enteral nutrition therapy, immunomodulators (eg, azathioprine [AZA], 6-mercaptopurine [6-MP], methotrexate [MTX]), and tumor necrosis factor-alpha (TNF-α) antagonists. The study will enroll approximately 120 patients. During the Induction Period participants will receive 3 doses of vedolizumab IV infusion at Day 1, Week 2, and Week 6 based on their weight at Baseline as:

  • - Participants ≥30 kg, Vedolizumab 300 mg.
  • - Participants >15 to <30 kg, Vedolizumab 200 mg.
  • - Participants 10 to 15 kg, Vedolizumab 150 mg.
At Week 14, participants who achieve clinical response will be randomly assigned (by chance, like flipping a coin) in a 1:1 ratio to 2 double-blind dose groups (high dose and low dose), stratified by previous exposure/failure to TNF-α antagonists therapy or naive to TNF-α antagonists therapy, and by weight groups. Participants will receive vedolizumab IV infusions every 8 weeks (Q8W) up to Week 46 during the Maintenance Period as follows:
  • - Participants ≥30 kg, Vedolizumab 300 mg (High dose) - Participants ≥30 kg, Vedolizumab 150 mg (Low dose) - Participants >15 to <30 kg, Vedolizumab 200 mg (High dose) - Participants >15 to <30 kg, Vedolizumab 100 mg (Low dose) - Participants 10 to 15 kg, Vedolizumab 150 mg (High dose) - Participants 10 to 15 kg, Vedolizumab 100 mg (Low dose) The dose will remain blinded to the participant and study doctor during the study (unless there is an urgent medical need).
All participants will be administered vedolizumab via IV infusion. In participants who demonstrate lack of maintenance of clinical response during the Maintenance Period the dose will be escalated in a blinded fashion to the high dose in their weight group based on the weight at the time of the worsening of disease. In addition one-time rescue therapy with corticosteroids is allowed. This multi-center trial will be conducted worldwide. After the Week 54, participants may be eligible to participate in extension study. Participants who do not roll over in the extension study will undergo a safety visit 18 weeks after the last dose of vedolizumab followed by 2 years of long term follow-up (up to 104 weeks). During this period a safety survey by telephone will be performed every 6 months for 2 years after the last dose of study drug.

Arms & Interventions

Arms

Experimental: Induction Period: ≥30 kg, Vedolizumab 300 mg

Vedolizumab 300 mg, intravenous (IV) infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of ≥30 kg will be included in this arm group.

Experimental: Induction Period: >15 to <30 kg, Vedolizumab 200 mg

Vedolizumab 200 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of >15 to <30 kg will be included in this arm group.

Experimental: Induction Period: 10 to 15 kg, Vedolizumab 150 mg

Vedolizumab 150 mg, IV infusion, at Day 1, Weeks 2 and 6 in Induction Period. Participants with CD having Baseline weight of 10 to 15 kg will be included in this arm group.

Experimental: Maintenance Period: ≥30 kg, Vedolizumab 300 mg

Vedolizumab 300 mg, IV infusion, once every 8 weeks (Q8W) from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 300 mg.

Experimental: Maintenance Period: ≥30 kg: Vedolizumab 150 mg

Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of ≥30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 150 mg.

Experimental: Maintenance Period: >15 to <30 kg, Vedolizumab 200 mg

Vedolizumab 200 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 200 mg.

Experimental: Maintenance Period: >15 to <30 kg Vedolizumab 100 mg

Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of >15 to <30 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.

Experimental: Maintenance Period: 10 to 15 kg Vedolizumab 150 mg

Vedolizumab 150 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this high dose arm group will receive vedolizumab 150 mg.

Experimental: Maintenance Period: 10 to 15 kg Vedolizumab 100 mg

Vedolizumab 100 mg, IV infusion, Q8W from Week 14 up to Week 46 in the Maintenance Period. Participants with Week 14 weight of 10 to 15 kg who achieved clinical response at Week 14 randomized to this low dose arm group will receive vedolizumab 100 mg.

Interventions

Drug: - Vedolizumab IV

Vedolizumab IV

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.

Phoenix Childrens Hospital, Phoenix, Arizona

Status

Not yet recruiting

Address

Phoenix Childrens Hospital

Phoenix, Arizona, 85016

Site Contact

Site Contact

apatel12@phoenixchildrens.com

602-933-0940

Cedars Sinai Medical Center, Los Angeles, California

Status

Not yet recruiting

Address

Cedars Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Site Contact

shervin.rabizadeh@cshs.org

310-423-7100

Rady Childrens Hospital San Diego - PIN, San Diego, California

Status

Not yet recruiting

Address

Rady Childrens Hospital San Diego - PIN

San Diego, California, 92123

Site Contact

Site Contact

yhuang815@163.com

381-688-2247 #+861

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94143

Site Contact

Site Contact

sofia.verstraete@ucsf.edu

415-476-5892

I.H.S Health LLC, Kissimmee, Florida

Status

Recruiting

Address

I.H.S Health LLC

Kissimmee, Florida, 34741

Site Contact

Site Contact

slateef@ihshealths.com

407-483-5389

Atlanta, Georgia

Status

Recruiting

Address

Childrens Center For Digestive Healthcare

Atlanta, Georgia, 30342

Site Contact

Site Contact

shlomico@tlvmc.gov.il

252-426-6988 #+97

Advocate Children's Hospital Park Ridge, Park Ridge, Illinois

Status

Recruiting

Address

Advocate Children's Hospital Park Ridge

Park Ridge, Illinois, 60068

Site Contact

Site Contact

Ts.Gunasekaran@aah.org

847-723-7700

Riley Hospital For Children, Indianapolis, Indiana

Status

Recruiting

Address

Riley Hospital For Children

Indianapolis, Indiana, 46202

Site Contact

Site Contact

mdelrosa@iupui.edu

317-274-3774

Johns Hopkins University, Baltimore, Maryland

Status

Not yet recruiting

Address

Johns Hopkins University

Baltimore, Maryland, 21287

Site Contact

Site Contact

moliva@jhmi.edu

141-095-5876 #9

Boston Children's Hospital, Boston, Massachusetts

Status

Not yet recruiting

Address

Boston Children's Hospital

Boston, Massachusetts, 02115

MNGI Digestive Health, PA, Minneapolis, Minnesota

Status

Recruiting

Address

MNGI Digestive Health, PA

Minneapolis, Minnesota, 55413

Site Contact

Site Contact

Ramalingam.Arumugam@mngi.com

612-813-7240

Mayo Clinic - PIN, Rochester, Minnesota

Status

Not yet recruiting

Address

Mayo Clinic - PIN

Rochester, Minnesota, 55905

Site Contact

Site Contact

stephens.michael@mayo.edu

507-266-0114

Goryeb Children's Hospital, Morristown, New Jersey

Status

Recruiting

Address

Goryeb Children's Hospital

Morristown, New Jersey, 07960

Site Contact

Site Contact

joel.rosh@atlantichealth.org

973-971-5676

New Hyde Park, New York

Status

Recruiting

Address

The Steven and Alexandra Cohen Childrens Medical Center of New York - BRANY - PPDS

New Hyde Park, New York, 11042

Site Contact

Site Contact

jmarkowi2@nshs.edu

516-472-3650

Rochester, New York

Status

Recruiting

Address

University of Rochester Medical Center PPDS

Rochester, New York, 14642

Site Contact

Site Contact

apatel12@phoenixchildrens.com

602-933-0940

Stony Brook University Medical Center, Stony Brook, New York

Status

Recruiting

Address

Stony Brook University Medical Center

Stony Brook, New York, 11794

SUNY Upstate Medical Center, Syracuse, New York

Status

Not yet recruiting

Address

SUNY Upstate Medical Center

Syracuse, New York, 13202

Site Contact

Site Contact

walip@upstate.edu

315-464-8444

Cleveland, Ohio

Status

Not yet recruiting

Address

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

Site Contact

Site Contact

jonathan.moses@uhhospitals.org

216-844-1765

Children's Hospital of Pittsburgh, Pittsburgh, Pennsylvania

Status

Not yet recruiting

Address

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15201

Site Contact

Site Contact

whitney.sunseri@chp.edu

412-692-6558

Hasbro Children's Hospital, Providence, Rhode Island

Status

Not yet recruiting

Address

Hasbro Children's Hospital

Providence, Rhode Island, 02903

Site Contact

Site Contact

Ssubedi1@lifespan.org

401-444-7167

Texas Children's Hospital, Houston, Texas

Status

Recruiting

Address

Texas Children's Hospital

Houston, Texas, 77030

Site Contact

Site Contact

faith.ihekweazu@bcm.edu

832-824-1000

Carilion Children's Tanglewood Center, Roanoke, Virginia

Status

Recruiting

Address

Carilion Children's Tanglewood Center

Roanoke, Virginia, 24018

Site Contact

Site Contact

jcolazagasti@carilionclinic.org

540-985-9832

International Sites

Children's Hospital at Westmead, Westmead, New South Wales, Australia

Status

Not yet recruiting

Address

Children's Hospital at Westmead

Westmead, New South Wales, 2145

Site Contact

Site Contact

shoma.dutt@health.nsw.gov.au

+61298453999

Queensland Childrens Hospital, South Brisbane, Queensland, Australia

Status

Recruiting

Address

Queensland Childrens Hospital

South Brisbane, Queensland, 4101

Monash Health, Monash Medical Centre, Clayton, Victoria, Australia

Status

Not yet recruiting

Address

Monash Health, Monash Medical Centre

Clayton, Victoria, 3168

Site Contact

Site Contact

Gregory.moore@monash.edu

+61395943177

Parkville, Victoria, Australia

Status

Not yet recruiting

Address

Royal Children's Hospital Melbourne - PIN

Parkville, Victoria, 3052

Site Contact

Site Contact

george.alex@rch.org.au

+0393455060

UZ Antwerpen, Edegem, Antwerpen, Belgium

Status

Not yet recruiting

Address

UZ Antwerpen

Edegem, Antwerpen, 2650

Site Contact

Site Contact

els.vandevijver@uza.be

+3238213810

Universitair Ziekenhuis Brussel - PIN, Jette, Brussels, Belgium

Status

Not yet recruiting

Address

Universitair Ziekenhuis Brussel - PIN

Jette, Brussels, 1090

Site Contact

Site Contact

elisabeth.degreef@uzbrussel.be

+32485022839

UZ Leuven, Leuven, Vlaams Brabant, Belgium

Status

Not yet recruiting

Address

UZ Leuven

Leuven, Vlaams Brabant, 3000

Site Contact

Site Contact

ilse.hoffman@uzleuven.be

+016343843

University of Alberta Hospital, Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

University of Alberta Hospital

Edmonton, Alberta, AB T6G 2B7

Site Contact

Site Contact

hien.huynh@ualberta.ca

(780) 248-5420

British Columbia Children's Hospital, Vancouver, British Columbia, Canada

Status

Not yet recruiting

Address

British Columbia Children's Hospital

Vancouver, British Columbia, V6H3V4

Site Contact

Site Contact

kjacobson@cw.bc.ca

(604) 377-1831

London Health Sciences Centre, London, Ontario, Canada

Status

Not yet recruiting

Address

London Health Sciences Centre

London, Ontario, N6A 4G5

Site Contact

Site Contact

kevin.bax@lhsc.on.ca

(519) 685-8500 x56836

Montreal, Quebec, Canada

Status

Not yet recruiting

Address

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec,

Beijing, Beijing, China

Status

Not yet recruiting

Address

Beijing Children Hospital,Capital Medical University

Beijing, Beijing, 100045

Site Contact

Site Contact

wujiedoc@163.com

+8618940251108

Zhengzhou, Henan, China

Status

Not yet recruiting

Address

Henan Children's Hospital(Zhengzhou Children's Hospital)

Zhengzhou, Henan, 450000

Site Contact

Site Contact

lixiaoqinys@126.com

+8615890105818

Children's Hospital of Fudan University, Shanghai, Shanghai, China

Status

Not yet recruiting

Address

Children's Hospital of Fudan University

Shanghai, Shanghai, 201102

Site Contact

Site Contact

yhuang815@163.com

+8613816882247

Hangzhou, Zhejiang, China

Status

Not yet recruiting

Address

The Children's Hospital Zhejiang UniversitySchool of Medicine

Hangzhou, Zhejiang, 310003

Site Contact

Site Contact

hzcjie@163.com

+8613858032920

Klinika Za Djecje Bolesti Zagreb, Zagreb, Grad Zagreb, Croatia

Status

Recruiting

Address

Klinika Za Djecje Bolesti Zagreb

Zagreb, Grad Zagreb, 10000

Site Contact

Site Contact

sanja.kolacek@gmail.com

+38514600291

University Hospital Center Zagreb, Zagreb, Grad Zagreb, Croatia

Status

Recruiting

Address

University Hospital Center Zagreb

Zagreb, Grad Zagreb, 10000

Site Contact

Site Contact

juricav1961@yahoo.com

+38598469865

University Hospital Centre Split, Split, Croatia

Status

Recruiting

Address

University Hospital Centre Split

Split, , 21000

Site Contact

Site Contact

ranka.despot11@gmail.com

+38598432200

Fakultni nemocnice Kralovske Vinohrady, Prague, Praha, Hlavni Mesto, Czechia

Status

Not yet recruiting

Address

Fakultni nemocnice Kralovske Vinohrady

Prague, Praha, Hlavni Mesto, 100 34

Site Contact

Site Contact

vladimir.volf@fnkv.cz

+420267163731

Fakultni Thomayerova Nemocnice, Praha, Praha, Hlavni Mesto, Czechia

Status

Not yet recruiting

Address

Fakultni Thomayerova Nemocnice

Praha, Praha, Hlavni Mesto, 140 00

Site Contact

Site Contact

radim.vyhnanek@ftn.cz

+420261083798

Fakultni nemocnice Ostrava, Ostrava, Czechia

Status

Not yet recruiting

Address

Fakultni nemocnice Ostrava

Ostrava, ,

Site Contact

Site Contact

astrida.sulakova@fno.cz

+420597371111

Attikon University General Hospital, Athens, Attiki, Greece

Status

Recruiting

Address

Attikon University General Hospital

Athens, Attiki, 124 62

Site Contact

Site Contact

vpapaev@gmail.com

+302105832228

Children's Hospital "Agia Sofia", Athens, Greece

Status

Recruiting

Address

Children's Hospital "Agia Sofia"

Athens, ,

Thessaloniki, Greece

Status

Not yet recruiting

Address

Ippokratio General Hospital of Thessaloniki

Thessaloniki, , 564 29

Site Contact

Site Contact

xinias@email.com

+302310992877

Thessaloniki, Greece

Status

Recruiting

Address

Ippokratio General Hospital of Thessaloniki

Thessaloniki, , 564 29

Site Contact

Site Contact

cagakidis@gmail.com

+306947687799

Miskolc, Borsod-Abauj-Zemplen, Hungary

Status

Recruiting

Address

Borsod-Abauj-Zemplen Megyei Kozponti Korhaz es Egyetemi Oktato Korhaz

Miskolc, Borsod-Abauj-Zemplen, 3526

Site Contact

Site Contact

szakos.iiigyek@bazmkorhaz.hu

+3646515200

Szeged, Csongrad, Hungary

Status

Recruiting

Address

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Csongrad, 6720

Site Contact

Site Contact

office.pedia@med.u-szeged.hu

+36302497404

Semmelweis Egyetem, Budapest, Hungary

Status

Not yet recruiting

Address

Semmelweis Egyetem

Budapest, , 1083

Site Contact

Site Contact

cseharon@gmail.com

+36208258186

Petah Tikva, HaMerkaz, Israel

Status

Not yet recruiting

Address

Schneider Childrens Medical Center of Israel Petah Tikvah PIN

Petah Tikva, HaMerkaz, 49202

Site Contact

Site Contact

raanan@shamirmd.com

+97239253672

Tel Aviv Sourasky Medical Center PPDS, Jerusalem, Yerushalayim, Israel

Status

Not yet recruiting

Address

Tel Aviv Sourasky Medical Center PPDS

Jerusalem, Yerushalayim, 90000

Site Contact

Site Contact

shlomico@tlvmc.gov.il

+972524266988

Soroka University Medical Centre, Beer Sheba, Israel

Status

Not yet recruiting

Address

Soroka University Medical Centre

Beer Sheba, , 84101

Site Contact

Site Contact

baruchy@clalit.org.il

+97286400653

Rambam Medical Center - PPDS, Haifa, Israel

Status

Not yet recruiting

Address

Rambam Medical Center - PPDS

Haifa, , 31096

Site Contact

Site Contact

r_shaoul@rambam.health.gov.il

+97248543388

Carmel Medical Center, Haifa, Israel

Status

Not yet recruiting

Address

Carmel Medical Center

Haifa, , 34362

Site Contact

Site Contact

corinah@clalit.org.il

+4056303

Shaare Zedek Medical Center, Jerusalem, Israel

Status

Not yet recruiting

Address

Shaare Zedek Medical Center

Jerusalem, , 91031

Site Contact

Site Contact

turnerd@szmc.org.il

+97226666482

Hadassah Medical Center - PPDS, Jerusalem, Israel

Status

Not yet recruiting

Address

Hadassah Medical Center - PPDS

Jerusalem, , 91120

Site Contact

Site Contact

mord@hadassah.org.il

+97226778637

Napoli, Campania, Italy

Status

Not yet recruiting

Address

AOU dell'Universita degli Studi della Campania Luigi Vanvitelli

Napoli, Campania, 80131

Napoli, Campania, Italy

Status

Not yet recruiting

Address

Azienda Ospedaliera Universitaria Federico II

Napoli, Campania, 80131

Site Contact

Site Contact

erasmo.miele@unina.it

+390817464565

Azienda USL di Bologna, Bologna, Emilia-Romagna, Italy

Status

Not yet recruiting

Address

Azienda USL di Bologna

Bologna, Emilia-Romagna, 40133

Sapienza University of Rome, Roma, Lazio, Italy

Status

Recruiting

Address

Sapienza University of Rome

Roma, Lazio, 161

Site Contact

Site Contact

marina.aloi@gmail.com

+390649979387

Monza, Lombardia, Italy

Status

Not yet recruiting

Address

ASST di Monza - Azienda Ospedaliera San Gerardo

Monza, Lombardia, 20900

Site Contact

Site Contact

r.panceri@asst-monza.it

+398888888888

Universita degli Studi di Padova, Padova, Veneto, Italy

Status

Not yet recruiting

Address

Universita degli Studi di Padova

Padova, Veneto, 35122

Site Contact

Site Contact

maracananzi@yahoo.com

+390498213517

Kurume University Hospital, Kurume-Shi, Hukuoka, Japan

Status

Recruiting

Address

Kurume University Hospital

Kurume-Shi, Hukuoka, 830-0011

Site Contact

Site Contact

mizuochi_tatsuki@kurume-u.ac.jp

+81942353311

Japanese Red Cross Kumamoto Hospital, Kumamoto-shi, Kumamoto, Japan

Status

Recruiting

Address

Japanese Red Cross Kumamoto Hospital

Kumamoto-shi, Kumamoto, 861-8520

Site Contact

Site Contact

tturmso@yahoo.co.jp

+81963842111

Juntendo University Hospital, Bunkyo-Ku, Tokyo, Japan

Status

Recruiting

Address

Juntendo University Hospital

Bunkyo-Ku, Tokyo, 113-8431

Site Contact

Site Contact

t-kudo@juntendo.ac.jp

+81338133111

Setagaya-Ku, Tokyo, Japan

Status

Recruiting

Address

National Center for Child Health and Development

Setagaya-Ku, Tokyo, 157-8535

Site Contact

Site Contact

arai-k@ncchd.go.jp

+81334160181

Daegu, Daegu Gwang'yeogsi, Korea, Republic of

Status

Recruiting

Address

Kyungpook National University Chilgok hospital

Daegu, Daegu Gwang'yeogsi, 41404

Site Contact

Site Contact

benkang@knu.ac.kr

+82532003780

Gachon University Gil Medical Center, Incheon, Incheon Gwang'yeogsi, Korea, Republic of

Status

Recruiting

Address

Gachon University Gil Medical Center

Incheon, Incheon Gwang'yeogsi, 21565

Site Contact

Site Contact

ryoo518@gilhospital.com

+82324603213

Seoul National University Hospital, Seongnam, Korea, Republic of

Status

Recruiting

Address

Seoul National University Hospital

Seongnam, , Seoul

Site Contact

Site Contact

mjschj@snu.ac.kr

+1-877-825-3327

Samsung Medical Center - PPDS, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center - PPDS

Seoul, , 6351

Site Contact

Site Contact

smc_yhc@naver.com

+82234103901

Kaunas, Kauno Apskritis, Lithuania

Status

Recruiting

Address

Hospital of Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, Kauno Apskritis, LT-50161

Site Contact

Site Contact

rutadrk@gmail.com

+37068646286

Vilnius, Vilniaus Apskritis, Lithuania

Status

Recruiting

Address

Vilnius University Hospital Santaros Klinikos

Vilnius, Vilniaus Apskritis, 8406

Site Contact

Site Contact

vaidotas.urbonas@santa.lt

+37060056127

Wroclaw, Dolnoslaskie, Poland

Status

Not yet recruiting

Address

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

Wroclaw, Dolnoslaskie, 50-369

Site Contact

Site Contact

as.stawarski@poczta.onet.pl

+48604213864

Instytut Centrum Zdrowia Matki Polki, Lodz, Lodzkie, Poland

Status

Not yet recruiting

Address

Instytut Centrum Zdrowia Matki Polki

Lodz, Lodzkie, 93-338

Site Contact

Site Contact

elcia@friend.pl

+48422711341

Uniwersytecki Szpital Dzieciecy, Krakow, Malopolskie, Poland

Status

Not yet recruiting

Address

Uniwersytecki Szpital Dzieciecy

Krakow, Malopolskie, 30-663

Site Contact

Site Contact

kingakd@mp.pl

+48123339330

WIP Warsaw IBD Point Profesor Kierkus, Warszawa, Mazowieckie, Poland

Status

Not yet recruiting

Address

WIP Warsaw IBD Point Profesor Kierkus

Warszawa, Mazowieckie, 00-728

Site Contact

Site Contact

m.meglicka@wip.waw.pl

+48226580456

Instytut Pomnik Centrum Zdrowia Dziecka, Warszawa, Mazowieckie, Poland

Status

Recruiting

Address

Instytut Pomnik Centrum Zdrowia Dziecka

Warszawa, Mazowieckie, 04-736

Site Contact

Site Contact

J.KIERKUS@IPCZD.PL

+486002111648

Korczowski Bartosz, Gabinet Lekarski, Rzeszow, Podkarpackie, Poland

Status

Recruiting

Address

Korczowski Bartosz, Gabinet Lekarski

Rzeszow, Podkarpackie, 35-302

Site Contact

Site Contact

korczowski@op.pl

+48177404065

Copernicus Podmiot Leczniczy Sp. z o.o., Gdansk, Pomorskie, Poland

Status

Not yet recruiting

Address

Copernicus Podmiot Leczniczy Sp. z o.o.

Gdansk, Pomorskie, 80-803

Site Contact

Site Contact

pland@gumed.edu.pl

+48583022591

Katowice, Slaskie, Poland

Status

Not yet recruiting

Address

Gornoslaskie Centrum Zdrowia Dziecka Im. Sw. Jana Pawla II Spsk Nr 6 Sum W Katowicach

Katowice, Slaskie, 40-752

Site Contact

Site Contact

urszulachlebowczyk@wp.pl

+48322071700

Twoja Przychodnia SCM, Szczecin, Zachodniopomorskie, Poland

Status

Recruiting

Address

Twoja Przychodnia SCM

Szczecin, Zachodniopomorskie, 71-434

Site Contact

Site Contact

gawdis@twojaprzychodnia.com

+48914332919

Lodz, Poland

Status

Not yet recruiting

Address

SPZOZ Centralny Szpital Kliniczny UM w Lodzi

Lodz, , 91-738

Research Center of Children's Health, Moscow, Moskva, Russian Federation

Status

Not yet recruiting

Address

Research Center of Children's Health

Moscow, Moskva, 119296

Site Contact

Site Contact

apotap@mail.ru

+79104688689

Moscow, Moskva, Russian Federation

Status

Not yet recruiting

Address

Russian Children's Clinical Hospital of the Ministry of Health of Russia

Moscow, Moskva, 119571

Kazan State Medical University, Kazan', Tatarstan, Respublika, Russian Federation

Status

Not yet recruiting

Address

Kazan State Medical University

Kazan', Tatarstan, Respublika, 420012

Site Contact

Site Contact

aelitakamalova@gmail.com

+78432373037

Krasnoyarsk, Russian Federation

Status

Not yet recruiting

Address

Krasnoyarsk State Medical University n.a. V.F. Voyno-Ysenetskiy

Krasnoyarsk, , 660074

Site Contact

Site Contact

vpanfiloff@mail.ru

+79135353628

Privolzhsky Research Medical University, Nizhny Novgorod, Russian Federation

Status

Not yet recruiting

Address

Privolzhsky Research Medical University

Nizhny Novgorod, , 603005

Site Contact

Site Contact

prof.kopeikin@gmail.com

+78314365659

Medical Company Hepatolog, LLC, Samara, Russian Federation

Status

Not yet recruiting

Address

Medical Company Hepatolog, LLC

Samara, , 443045

Site Contact

Site Contact

alenamalova@mail.ru

+79033357481

Banska Bystrica, Slovakia

Status

Recruiting

Address

Detska fakultna nemocnica s poliklinikou Banska Bystrica

Banska Bystrica, , 974 09

Site Contact

Site Contact

ivalachova@dfnbb.sk

+421484726513

Narodny ustav detskych chorob, Bratislava, Slovakia

Status

Not yet recruiting

Address

Narodny ustav detskych chorob

Bratislava, , 833 40

Site Contact

Site Contact

iicierna@gmail.com

+421259371240

Hospital Sant Joan de Deu - PIN, Esplugues de Llobregat, Barcelona, Spain

Status

Recruiting

Address

Hospital Sant Joan de Deu - PIN

Esplugues de Llobregat, Barcelona, 8950

Site Contact

Site Contact

javier.martinc@sjd.es

+34871205705

Hospital de Sagunto, Sagunto, Valencia, Spain

Status

Recruiting

Address

Hospital de Sagunto

Sagunto, Valencia, 46520

Site Contact

Site Contact

laurasanchisartero@gmail.com

+34962659414

Madrid, Spain

Status

Recruiting

Address

Hospital Infantil Universitario Nino Jesus - PIN

Madrid, , 28009

Site Contact

Site Contact

martavrb@gmail.com

+34915035900

Malaga, Spain

Status

Recruiting

Address

Hospital Regional Universitario de Malaga - Hospital Materno Infantil

Malaga, , 29011

Site Contact

Site Contact

victor.navas@gmail.com

+34951292143

Sevilla, Spain

Status

Recruiting

Address

Hospital Universitario Virgen del Rocio - PPDS

Sevilla, , 41013

Kharkiv, Kharkivs'ka Oblast, Ukraine

Status

Not yet recruiting

Address

Municipal Non-profit Enterprise of Kharkiv Regional Council Regional Childrens Clinical Hospital

Kharkiv, Kharkivs'ka Oblast, 61093

Site Contact

Site Contact

omelchenkohelen@gmail.com

+380667852356

Kyiv, Ukraine

Status

Not yet recruiting

Address

Clinic of SI National Scientific Center of Radiological Medicine of NAMS of Ukraine

Kyiv, , 3115

Site Contact

Site Contact

viktor.zygalo@ukr.net

+380504809129

Kyiv, Ukraine

Status

Not yet recruiting

Address

State Institution Institute of Pediatrics, Obstetrics and Gynecology of NAMS Ukraine

Kyiv, , 4050

Site Contact

Site Contact

valentynaberezenko@gmail.com

+380508565610

Kings College Hospital, London, London, City Of, United Kingdom

Status

Not yet recruiting

Address

Kings College Hospital

London, London, City Of, SE5 9RS

Site Contact

Site Contact

babu.vadamalayan@nhs.net

+442032991674

Great Ormond Street Hospital (GOSH), London, London, City Of, United Kingdom

Status

Not yet recruiting

Address

Great Ormond Street Hospital (GOSH)

London, London, City Of, WC1N 3AJ

Site Contact

Site Contact

kelsey.jones@gosh.nhs.uk

+447779142231

Cardiff, South Glamorgan, United Kingdom

Status

Not yet recruiting

Address

Noahs Ark Childrens Hospital for Wales - PPDS - PIN

Cardiff, South Glamorgan, CF14 4XW

Site Contact

Site Contact

amar.wahid@wales.nhs.uk

+448888888888

Birmingham, West Midlands, United Kingdom

Status

Not yet recruiting

Address

Birmingham Children's Hospital NHS Foundation Trust

Birmingham, West Midlands, B4 6NH

Site Contact

Site Contact

rafeeq.muhammed@nhs.net

+4401213338705

Barts Health NHS Trust, London, United Kingdom

Status

Not yet recruiting

Address

Barts Health NHS Trust

London, , E1 1BB

Site Contact

Site Contact

marco.gasparetto@nhs.net

+448888888888

Manchester, United Kingdom

Status

Not yet recruiting

Address

Royal Manchester Children's Hospital - PPDS

Manchester, , M27 4HA

Site Contact

Site Contact

andrew.fagbemi@mft.nhs.uk

+441617012371

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