An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease

Last updated: September 28, 2023
Sponsor: Genentech, Inc.
Overall Status: Terminated

Phase

2

Condition

Colic

Ulcers

Inflammatory Bowel Disease

Treatment

UTTR1147A

Clinical Study ID

NCT03650413
GA40209
2017-004997-32
  • Ages 18-80
  • All Genders

Study Summary

This study will evaluate the long-term safety and tolerability of UTTR1147A in participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320 participants from the parent studies: Phase Ib Study GA29469 (NCT02749630) and Phase II Study GA39925 (NCT03558152).

Eligibility Criteria

Inclusion

Inclusion Criteria: Inclusion Criteria for Study Entry:

  • Prior enrollment in Study GA29469 or Study GA39925 and meeting protocol defined entrycriteria Inclusion Criteria for Study Entry and Study Re-Entry:
  • Ability to comply with requirements of the study, in the investigator's judgment
  • For women and men: use of highly effective contraception as defined by the protocol.

Exclusion

Exclusion Criteria: Exclusion Criteria for Study Entry:

  • Withdrawal of consent from parent study
  • Discontinuation of study drug as required by the parent study protocol
  • Discontinuation of study drug and withdrawal from Study GA29469 prior to Day 85 orfrom Study GA39925 prior to Week 8
  • Noncompliance in the parent study, specifically defined as missing scheduled visits ornon-adherence with background medications and concomitant medications Exclusion Criteria for Study Entry and Study Re-Entry:
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 8 weeks after the final dose of study drug or within 18 weeks after the final dose ofstudy drug from GA39925, whichever is longer
  • Any new malignancy, significant uncontrolled comorbidity, such as cardiac, pulmonary,renal, hepatic, endocrine, or gastrointestinal disorders, or signs or symptoms ofinfection judged by the investigator to be clinically significant since enrolling inthe parent study
  • Use of prohibited therapies as defined in the parent study
  • Abnormal laboratory values, as defined in the protocol, recorded at the last visit inthe parent study Exclusion Criterion for Study Re-Entry:
  • Use of prohibited concomitant therapy since enrolling in the extension study

Study Design

Total Participants: 143
Treatment Group(s): 1
Primary Treatment: UTTR1147A
Phase: 2
Study Start date:
January 14, 2019
Estimated Completion Date:
July 12, 2022

Connect with a study center

  • MHAT Saint Karidad EAD

    Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment Hadji Dimitar OOD

    Sliven, 8800
    Bulgaria

    Site Not Available

  • Synexus - Medical Center Synexus Sofia EOOD

    Sofia, 1784
    Bulgaria

    Site Not Available

  • Synexus - Medical Centre Synexus Sofia EOOD (branch - Stara Zagora)

    Stara Zagora, 6000
    Bulgaria

    Site Not Available

  • Medical Center Medica Plus OOD

    Veliko Tarnovo, 5000
    Bulgaria

    Site Not Available

  • Peking University Third Hospital

    Beijing, 100083
    China

    Site Not Available

  • Beijing Chaoyang Hospital Capital Medical University

    Beijing City, 100020
    China

    Site Not Available

  • Third Xiangya Hospital Centrel South University

    Changsha, 410013
    China

    Site Not Available

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu City, 610072
    China

    Site Not Available

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510655
    China

    Site Not Available

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou City, 510080
    China

    Site Not Available

  • Affiliated Hospital of Guilin Medical University

    Guilin City, 541001
    China

    Site Not Available

  • Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

    Hangzhou, 310016
    China

    Site Not Available

  • Nanjing First Hospital

    Nanjing City, 210029
    China

    Site Not Available

  • Shanghai General Hospital

    Shanghai, 201620
    China

    Site Not Available

  • Renji Hospital Shanghai Jiaotong University School of Medicine

    Shanghai City, 200127
    China

    Site Not Available

  • Tianjin Medical University General Hospital

    Tianjin (天津), 300052
    China

    Site Not Available

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan City, 430030
    China

    Site Not Available

  • Zhongshan Hospital Xiamen University

    Xiamen, 361004
    China

    Site Not Available

  • CHU Amiens Picardie- Hôpital Nord

    Amiens, 80054
    France

    Site Not Available

  • Hopital Cote De Nacre; Hematologie Clinique

    Caen, 14033
    France

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    Grenoble, 38043
    France

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    Lille, 59037
    France

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    Nice, 06202
    France

    Site Not Available

  • CHU du Reims - Hopital Robert Debré

    Reims, 51092
    France

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  • LLC ARENSIA Exploratory Medicine

    Tbilisi, 0112
    Georgia

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  • Gastroenterologische Spezialpraxis-Berlin-Karlshorst

    Berlin, 10318
    Germany

    Site Not Available

  • Universitätsklinikum "Carl Gustav Carus" der Technischen Universität Dresden

    Dresden, 01307
    Germany

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    Frankfurt, 60313
    Germany

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    Hamburg, 22559
    Germany

    Site Not Available

  • KRH Klinikum Siloah

    Hannover, 30459
    Germany

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  • Universitätsklinikum Jena; Klinik und Poliklinik für Frauenheilkunde und Fortpflanzungsmedizin

    Jena, 07747
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    Kiel, 24105
    Germany

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    Germany

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    Ludwigshafen, 67067
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    Mannheim, 68167
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    Münster, 48149
    Germany

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    Regensburg, 93053
    Germany

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    Ulm, 89081
    Germany

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  • University General Hospital of Heraklion; Department of Ophthalmology

    Heraklion, 71110
    Greece

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    Heraklon, 711 10
    Greece

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  • University General Hospital of Larissa; University Gastroenterology Clinic

    Larissa, 41110
    Greece

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    Palaio Faliro, 175 62
    Greece

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    Thessaloniki, 54645
    Greece

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    Budapest, 1036
    Hungary

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    Dunaújváros, 2400
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    Gyula, 5700
    Hungary

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    Mosonmagyaróvár, 9200
    Hungary

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    Szentes, 6600
    Hungary

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    Székesfehérvár, 8000
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    Veszprém, 8200
    Hungary

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    Co Galway,
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    Dublin,
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    Beer Sheva, 8410100
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    Beer-Sheva, 84101
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    Jerusalem, 9103102
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    Kfar Saba, 44281
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    Kfar- Saba, 4428164
    Israel

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    Nahariyya, 22100
    Israel

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    Petach Tiqwa, 49100
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    Ramat Gan, 5265601
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    Rehovot, 76100
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    Tel Hashomer, 52661
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    Bologna, Emilia-Romagna 40138
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    Udine, Friuli-Venezia Giulia 33100
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    Roma, Lazio 00168
    Italy

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    Milano, Lombardia 20157
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    Monza, Lombardia 20900
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    Rho, Lombardia 20017
    Italy

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    Rozzano (MI), Lombardia 20089
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    Ancona, Marche 60020
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    Torino, Piemonte 10128
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  • Azienda Ospedaliera Universitaria Careggi

    Firenze, Toscana 50141
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  • Azienda Ospedaliera Di Padova

    Padova, Veneto 35128
    Italy

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  • ICS ARENSIA Exploratory Medicine

    Chisinau, MD-2025
    Moldova, Republic of

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  • ETZ-Elisabeth; Cardiologie

    Tilburg, 5022 GC
    Netherlands

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  • SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.

    ?ód?, 90-153
    Poland

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  • Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy; Centrum Endoskopii Zabiegowej

    Bydgoszcz, 85-168
    Poland

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  • Centrum Medyczne Lukamed Joanna Luka-Wendrowska

    Chojnice, 89-600
    Poland

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  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie

    Cz?stochowa, 42-202
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  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Czestochowie

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  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Gdansku

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    Gdańsk, 80-382
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  • Synexus Polska Sp. z o.o. Oddzial w Gdyni

    Gdynia, 81-537
    Poland

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  • AES - DRS - Synexus Polska Sp. z o.o. Oddzial w Katowicach

    Katowice, 40-040
    Poland

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  • ETG Kielce

    Kielce, 25-355
    Poland

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  • Gastromed SPK Niepubliczny Zaklad Opieki Zdrowotnej

    Lublin, 20-582
    Poland

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  • Allmedica Badania Kliniczne Sp z o.o. Sp K.

    Nowy Targ, 34-400
    Poland

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    Piotrków Trybunalski, 97-300
    Poland

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  • Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

    Pozna?, 61-731
    Poland

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    Poznan, 60-702
    Poland

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  • Clinical Research Center Sp. z o.o. MEDIC-R Spółka Komandytowa

    Poznań, 61-731
    Poland

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  • Gabinet Lekarski, Bartosz Korczowski

    Rzeszów, 35-302
    Poland

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  • Endoskopia Sp. z o.o.

    Sopot, 81-756
    Poland

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    Szczecin, 71-685
    Poland

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  • Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj

    Toruń, 87-100
    Poland

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  • Centrum Zdrowia MDM

    Warszawa, 00-635
    Poland

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  • WIP Warsaw IBD Point Profesor Kierkus

    Warszawa, 00-728
    Poland

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  • Centrum Diagnostyczno - Lecznicze Barska sp. z o.o.

    Wloclawek, 87-800
    Poland

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  • Melita Medical

    Wroc?aw, 50-449
    Poland

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    Wroc?aw, 50-220
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    Wroclaw, 50-088
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    Wrocław, 50-220
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    Wrocław, 50-449
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  • ETG Zamosc

    Zamosc, 22-400
    Poland

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  • Osrodek Badan Klinicznych Appletreeclinics

    Łódź, 90-349
    Poland

    Site Not Available

  • SPZOZ Uniwersytecki SK nr 1 im N. Barlickiego UM w Lodzi; Oddz. Klin. Gastroenter. Og. i Onk.

    Łódź, 90-153
    Poland

    Site Not Available

  • Moscow Regional Research Clinical Institute Na Mfvladimirskiy

    Moscow, Moskovskaja Oblast 129110
    Russian Federation

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  • North-West State Medical University n.a. I.I. Mechnikov

    Sankt-peterburg, Sankt Petersburg 191015
    Russian Federation

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  • Saint Martyr Elizabeth City Hospital

    Sankt-peterburg, Sankt Petersburg 195257
    Russian Federation

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  • Irkutsk Research Centre Hospital of Siberian department of Russian Academy of Science

    Irkutsk, 664033
    Russian Federation

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  • Kuban State Medical University

    Krasnodar, 350000
    Russian Federation

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  • Regional Clinical Hospital

    Krasnoyarsk, 660022
    Russian Federation

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  • Research Institute of Physiology and Basic Medicine

    Novosibirsk, 630117
    Russian Federation

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  • Rostov State Medical University; Cardiorheumatology Department

    Rostov-na-Donu, 344022
    Russian Federation

    Site Not Available

  • Medical University Reaviz

    Samara, 443011
    Russian Federation

    Site Not Available

  • North-West State Medical University n.a. I.I. Mechnikov

    St. Petersburg, 191015
    Russian Federation

    Site Not Available

  • Russian Medical Military Academy n.a. S.M. Kirov

    St. Petersburg, 194044
    Russian Federation

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  • Tomsk Regional Clinical Hospital

    Tomsk, 634063
    Russian Federation

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  • KBC Dr Dragisa Misovic Dedinje

    Belgrade, 11000
    Serbia

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    Belgrade, 11080
    Serbia

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    Kragujevac, 34000
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    NIS, 18000
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    Vrsac, 26300
    Serbia

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    Zemun, 11080
    Serbia

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  • General Hospital Djordje Joanovic - Zrenjanin

    Zrenjanin, 23000
    Serbia

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  • Hospital de Gran Canaria Dr. Negrin; Servicio de Aparato Digestivo

    Las Palmas de Gran Canaria, LAS Palmas 35010
    Spain

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    Torrejon de Ardoz, Madrid 28850
    Spain

    Site Not Available

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    Barcelona, 8022
    Spain

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  • Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007
    Spain

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  • Hospital Universitario de La Princesa; Aparato Digestivo

    Madrid, 28006
    Spain

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  • Complejo Asistencial Universitario de Salamanca - H. Clinico

    Salamanca, 37007
    Spain

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  • Hospital Clinico Universitario de Valencia; Servicio de Neurologia

    Valencia, 46010
    Spain

    Site Not Available

  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital

    Chernivtsi, Chernihiv Governorate 58005
    Ukraine

    Site Not Available

  • Medical Centre of PE First Private Clinic

    Zhytomir, Crimean Regional Governmenta 10008
    Ukraine

    Site Not Available

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    Dnipro, KIEV Governorate 49005
    Ukraine

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    Kropyvnytskyi, KIEV Governorate 25005
    Ukraine

    Site Not Available

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    Kyiv, KIEV Governorate 2091
    Ukraine

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    Kyiv, KIEV Governorate 02002
    Ukraine

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    Kyiv, KIEV Governorate 02000
    Ukraine

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    Kyiv, KIEV Governorate 01001
    Ukraine

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    Kyiv, KIEV Governorate 01135
    Ukraine

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    Kyiv, KIEV Governorate 01135
    Ukraine

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    Kyiv, KIEV Governorate 03037
    Ukraine

    Site Not Available

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    Vinnyts, KIEV Governorate 21018
    Ukraine

    Site Not Available

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    Ternopil, Katerynoslav Governorate 46002
    Ukraine

    Site Not Available

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    Zaporizhzhye, Katerynoslav Governorate 69063
    Ukraine

    Site Not Available

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    Kharkiv, Kharkiv Governorate 61037
    Ukraine

    Site Not Available

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    Kozyn, Kharkiv Governorate 08711
    Ukraine

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    Zaporizhzhia, Kharkiv Governorate 69600
    Ukraine

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    Vinnytsia, Podolia Governorate 21029
    Ukraine

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    Dnipr, Polissya Okruha 49600
    Ukraine

    Site Not Available

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    Lviv, Polissya Okruha 79059
    Ukraine

    Site Not Available

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    Uzhgorod, 88000
    Ukraine

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    Zaporizhzhia, 69035
    Ukraine

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    Birmingham, B15 2SQ
    United Kingdom

    Site Not Available

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    Cardiff, CF15 9SS
    United Kingdom

    Site Not Available

  • Kings College Hospital

    London, SW9 8RR
    United Kingdom

    Site Not Available

  • Synexus - Manchester Clinical Research Centre

    Manchester, M15 6SX
    United Kingdom

    Site Not Available

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Care Access Research

    San Pablo, California 94806
    United States

    Site Not Available

  • QWay Research

    Hialeah, Florida 33010
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Gastroenterology Group of Naples

    Naples, Florida 34102
    United States

    Site Not Available

  • University of Chicago Medical Center

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Clinical Research Institute of Michigan

    Chesterfield, Michigan 48047
    United States

    Site Not Available

  • Atlantic Health System

    Morristown, New Jersey 07960
    United States

    Site Not Available

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York 11021
    United States

    Site Not Available

  • Weill Cornell Medical College

    New York, New York 10065
    United States

    Site Not Available

  • Southtowns Gastroenterology, PLLC

    Orchard Park, New York 14127
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • Syracuse VA Medical Center - NAVREF; Pharmacy

    Syracuse, New York 13210
    United States

    Site Not Available

  • Carolina Digestive Diseases

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Gastro One

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Vanderbilt University Medical Center; IBD Clinic

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Vilo Research Group

    Houston, Texas 77017
    United States

    Site Not Available

  • Tyler Research Institute, LLC

    Tyler, Texas 75701
    United States

    Site Not Available

  • Texas Digestive Disease Consultants - PPDS

    Webster, Texas 77598
    United States

    Site Not Available

  • University of Utah; Division of Gastroenterology/Hepatology

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • The Medical College of Wisconsin Inc.

    Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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