Pompe Pregnancy Sub-Registry

Recruiting Observational Study
Glycogen Storage Disease Type II (GSD-II) Pompe Disease (Late-onset) Glycogenesis 2 Acid Maltase Deficiency
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Sex
Female
Study type
Observational
Participants needed
20 (estimated)
Sponsor
Genzyme, a Sanofi Company · Industry
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About This Trial
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 exp…
Trial Locations
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Eligibility Criteria
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-Regist…
Contacts

Trial Transparency email recommended (Toll free number for US & Canada)

800-633-1610

Contact-us@sanofi.com

CONTACT

Pompe Registry HelpLine

617-591-5500

CONTACT