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Набира участници NCT00567073

Pompe Pregnancy Sub-Registry

Заболявания: Glycogen Storage Disease Type II (GSD-II) Pompe Disease (Late-onset) Glycogenesis 2 Acid Maltase Deficiency

Спонсор: Genzyme, a Sanofi Company

Налично на: БГ
Обобщение
This Sub-registry is a multicenter, international, longitudinal, observational, and voluntary program designed to track pregnancy outcomes for any pregnant woman enrolled in the Pompe Registry, regardless of whether she is receiving disease-specific therapy (such as ERT with alglucosidase alfa or avalglucosidase alfa) and irrespective of the commercial product with which she may be treated. No experimental intervention is given; thus a patient will undergo clinical assessments and receive standard of care treatment as determined by the patient's physician. The primary objective of this Sub-registry is to track pregnancy outcomes, including complications and infant growth, in all women with Pompe disease during pregnancy, regardless of whether they receive disease-specific therapy, such as ERT with alglucosidase alfa or avalglucosidase alfa.
Описание
Study Design Time Perspective: Retrospective and Prospective
Кой може да участва
Inclusion Criteria: Eligible women must: * be enrolled in the Pompe registry (NCT00231400) * be pregnant, or have been pregnant with appropriate medical documentation available. * provide a signed informed consent and authorization form(s) to participate in the Sub-Registry prior to any Sub-Registry-related data collection being performed. Note: It is recommended that pregnancy data be collected on eligible women regardless of infant enrollment. In the event of patients having multiple pregnancies, participation in this Sub-Registry is encouraged for each individual pregnancy. Exclusion Criteria: There are no exclusion criteria for this Sub-Registry
Места на провеждане 9
Австралия (1)
Investigational Site Number : 151069
Westmead , New South Wales
Белгия (1)
Investigational Site Number : 056001
Ghent
Бразилия (1)
Instituto de Genética e Erros Inatos do Metabolismo- Site Number : 150978
São Paulo
Хърватия (1)
Investigational Site Number : 1910001
Zagreb
Чехия (1)
Investigational Site Number : 2030001
Prague
Германия (1)
Investigational Site Number : 152200
Bonn
Италия (1)
Investigational Site Number : 380005
Florence , Firenze
Великобритания (1)
Investigational Site Number : 87147
Cardiff , Cardiff [Caerdydd Gb-crd]
САЩ (1)
Barrow Neurol Group- Site Number : 840087
Phoenix , Arizona
Технически детайли
Статус
Набира участници
Вид изследване
OBSERVATIONAL
Пол
Само жени
Здрави доброволци
Не
Начална дата
18.06.2007
Крайна дата
31.01.2034
Регистрационен номер
NCT00567073
Източник
anzctr
Запитване за медицински туризъм

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