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Набира участници Фаза 3 NCT04844606

A Master Protocol (AMAZ): A Study of Mirikizumab (LY3074828) in Pediatric Participants With Ulcerative Colitis or Crohn's Disease (SHINE-ON)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Ulcerative Colitis Ulcerative Colitis Chronic Inflammatory Bowel Diseases Crohn's Disease

Спонсор: Eli Lilly and Company

Налично на: БГ
Обобщение
The main purpose of this study is to evaluate the long-term efficacy of mirikizumab in pediatric participants with ulcerative colitis (UC) or Crohn's disease (CD). The study will last about 172 weeks and may include up to 44 visits. Additional treatment may be available to participants via a Continued Access Period.
Кой може да участва
Inclusion Criteria: * Participants from originating studies (I6T-MC-AMBA \[NCT05784246\], I6T-MC-AMBU \[NCT04004611\], I6T-MC-AMAM \[NCT03926130\]) , I6T-MC-AMAY \[NCT05509777\]) who would, in the opinion of the investigator, derive clinical benefit from further treatment with mirikizumab * Participants from prior studies who have completed assessments and procedures at last visit of originating study and remain on study drug treatment. * Female participants must agree to contraception requirements. Exclusion Criteria: * Participants must not have developed a serious adverse event (SAE) or Adverse Event (AE) in originating study or developed other condition before first visit of Study AMAZ that continued treatment with mirikizumab would present an unreasonable risk for the participant. * Participants must not have had permanently or temporarily stopped study drug in the originating study, such that restarting mirikizumab would pose an unacceptable risk for the participant in Study AMAZ. * Participants must not have an unstable or uncontrolled illness that would potentially affect participant safety. * Participants must not be enrolled in the study if, for any reason, being in the study would compromise the participant's safety or confound data interpretation. * Participants must not have adenomatous polyps that have not been removed. * Participants must not be pregnant or breastfeeding.
Интервенции
Mirikizumab
DRUG
Mirikizumab
DRUG
Места на провеждане 66
Австрия (1)
Medizinische Universität Wien
Vienna
NOT_YET_RECRUITING
Белгия (5)
UZ Brussel
Brussels
NOT_YET_RECRUITING
Cliniques universitaires Saint-Luc
Brussels
NOT_YET_RECRUITING
Antwerp University Hospital
Edegem
NOT_YET_RECRUITING
UZ Gent
Ghent
NOT_YET_RECRUITING
UZ Leuven
Leuven
Бразилия (7)
Centro de Pesquisa Sao Lucas
Campinas
NOT_YET_RECRUITING
Hospital Pequeno Príncipe / Associação Hospitalar de Proteção à Infância
Curitiba
NOT_YET_RECRUITING
Universidade Federal de Goias
Goiânia
NOT_YET_RECRUITING
Hospital de Clinicas de Porto Alegre
Porto Alegre
NOT_YET_RECRUITING
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre
NOT_YET_RECRUITING
Hospital Universitario Cassiano Antonio de Moraes
Vitória
NOT_YET_RECRUITING
Integral Pesquisa e Ensino
Votuporanga
NOT_YET_RECRUITING
Канада (2)
London Health Sciences Centre
London
NOT_YET_RECRUITING
The Hospital for Sick Children
Toronto
NOT_YET_RECRUITING
Германия (2)
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz
Dr. von Haunersches Kinderspital
Munich
Израел (5)
Rambam Health Care Campus
Haifa
NOT_YET_RECRUITING
Shaare Zedek Medical Center
Jerusalem
Hadassah Medical Center
Jerusalem
Schneider Children's Medical Center
Petah Tikva
Yitzhak Shamir Medical Center
Ẕerifin
Италия (6)
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo
NOT_YET_RECRUITING
Ospedale Maggiore Azienda USL di Bologna
Bologna
NOT_YET_RECRUITING
Azienda Ospedaliera Universitaria Meyer IRCCS
Florence
Ospedale dei Bambini Vittore Buzzi
Milan
AOU Policlinico Umberto I
Roma
Ospedale Pediatrico Bambino Gesù IRCCS
Rome
NOT_YET_RECRUITING
Япония (6)
Institute of Science Tokyo Hospital
Bunkyō
Juntendo University Hospital
Bunkyō City
Tsujinaka Hospital - Kashiwanoha
Kashiwa
Kobe University Hospital
Kobe
NOT_YET_RECRUITING
National Center for Child Health and Development
Tokyo
NOT_YET_RECRUITING
Yokohama City University Medical Center
Yokohama
NOT_YET_RECRUITING
Нидерландия (1)
Erasmus Medisch Centrum
Rotterdam
NOT_YET_RECRUITING
Норвегия (4)
Akershus Universitetssykehus
Lørenskog
NOT_YET_RECRUITING
Oslo Universitetssykehus Ullevål
Oslo
NOT_YET_RECRUITING
Universitetssykehuset Nord-Norge HF
Tromsø
NOT_YET_RECRUITING
St. Olavs Hospital
Trondheim
NOT_YET_RECRUITING
Полша (5)
Korczowski Bartosz, Gabinet Lekarski
Rzeszów
Twoja Przychodnia SCM
Szczecin
Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
Warsaw
Centrum Zdrowia Dziecka w Warszawie
Warsaw
Centrum Medyczne Oporów
Wroclaw
Португалия (2)
2Ca Braga
Braga
NOT_YET_RECRUITING
Centro Hospitalar de Sao Joao - Hospital de Sao Joao
Porto
Южна Корея (3)
Kyungpook National University Chilgok Hospital
Deagu
Seoul National University Hospital
Seoul
Samsung Medical Center
Seoul
Испания (4)
Hospital Universitario Reina Sofia
Córdoba
NOT_YET_RECRUITING
Hospital Sant Joan de Déu
Esplugues de Llobregat
NOT_YET_RECRUITING
Hospital Universitari Parc Tauli
Sabadell
NOT_YET_RECRUITING
Hospital Universitari i Politecnic La Fe
Valencia
NOT_YET_RECRUITING
Великобритания (3)
Royal London Hospital
London
NOT_YET_RECRUITING
The John Radcliffe Hospital
Oxford
NOT_YET_RECRUITING
Sheffield Children's Hospital
Sheffield
САЩ (10)
Emory University School of Medicine
Atlanta , Georgia
Children's Center for Digestive Health Care, LLC
Atlanta , Georgia
Boston Children's Hospital
Boston , Massachusetts
Pediatric Specialists of Virginia
Fairfax , Virginia
NOT_YET_RECRUITING
Cook Children's Medical Center
Fort Worth , Texas
Connecticut Children's Medical Center
Hartford , Connecticut
Icahn School of Medicine at Mount Sinai
New York , New York
UCSF Medical Center at Mission Bay
San Francisco , California
Washington University School of Medicine
St Louis , Missouri
Massachusetts General Hospital
Waltham , Massachusetts
Технически детайли
Статус
Набира участници
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Максимална възраст
19 Years
Здрави доброволци
Не
Начална дата
26.05.2021
Крайна дата
01.12.2030
Регистрационен номер
NCT04844606
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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