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Набира участници NCT06636383

Glycogen Storage Disease Type Ia (GSDIa) Disease Monitoring Program

Заболявания: Glycogen Storage Disease Type Ia

Спонсор: Ultragenyx Pharmaceutical Inc

Налично на: БГ
Обобщение
The main objective of this observational study is to evaluate the long-term safety and effectiveness of DTX401 for at least 10 years after DTX401 administration.
Описание
The DTX401-CL401 Disease Monitoring Program (DMP) is a prospective, multicenter, long-term observational study to follow up participants with GSDIa for at least 10 years after the administration of DTX401.
Кой може да участва
Inclusion Criteria: * Patient who had: * DTX401 (full or partial dose) administered in a parent clinical study (Group 1) or * Prescribed DTX401(full or partial dose) administered in a post-marketing setting (Group 2) * Patient is willing and able to provide informed consent after the nature of the study has been explained, and prior to any research-related assessments or procedures. If a minor or an adult with cognitive limitations, the patient is willing and able (if possible) to provide assent and have a legally authorized representative provide informed consent after the nature of the study has been explained, and prior to any research-related assessments or procedures. Exclusion Criteria: * Presence of any condition that would interfere with study participation, interpretation of results or affect patient's safety in the opinion of the Investigator
Интервенции
No Intervention
OTHER
Места на провеждане 19
Бразилия (1)
Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
Porto Alegre , Rio Grande do Sul
Канада (1)
McGill University Health Center
Montreal , Quebec
Дания (1)
Rigshospitalet
Copenhagen
Германия (1)
Universitätsklinikum Hamburg Eppendorf
Hamburg
Италия (2)
Istituto G Gaslini Ospedale Pediatrico IRCCS
Genoa
University of Naples
Naples , Campania
Япония (2)
Osaka City General Hospital
Osaka
Fujita Health University Hospital
Toyoake
Нидерландия (1)
Groningen University
Groningen
Испания (1)
Hospital Clínico Universitario de Santiago
Santiago
САЩ (9)
University of Michigan
Ann Arbor , Michigan
The Cleveland Clinic Foundation
Cleveland , Ohio
NOT_YET_RECRUITING
Children's Hospital Colorado
Denver , Colorado
Duke University Medical Center
Durham , North Carolina
University of Connecticut Health Center
Hartford , Connecticut
University of Texas Health Science Center at Houston
Houston , Texas
Children's Hospital of Orange County
Orange , California
Children's Hospital of Philadelphia
Philadelphia , Pennsylvania
Primary Children's Hospital
Salt Lake City , Utah
NOT_YET_RECRUITING
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Мъже и жени
Минимална възраст
2 Years
Здрави доброволци
Не
Начална дата
04.11.2024
Крайна дата
01.12.2036
Регистрационен номер
NCT06636383
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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