Pompe Pregnancy Sub-Registry

  • STATUS
    Recruiting
  • End date
    Jan 31, 2034
  • participants needed
    20
  • sponsor
    Genzyme, a Sanofi Company
Updated on 19 February 2024

Summary

The objective is to track pregnancy outcomes in women with Pompe Disease and to follow infants born to women with Pompe Disease.

Description

Study Design Time Perspective: Retrospective and Prospective

Details
Condition Glycogen storage disease type II, pompe disease, pompe disease, Glycogenesis 2 Acid Maltase Deficiency
Age 100years or below
Treatment alglucosidase alpha, No Treatment
Clinical Study IdentifierNCT00567073
SponsorGenzyme, a Sanofi Company
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

Enroll in or agree to enroll in Pompe Registry
Be pregnant or have been pregnant with appropriate medical documentation
Provide a signed Patient Information and Authorization Form to participate in the sub-registry prior to any sub-registry related data collection is performed

Exclusion Criteria

No Exclusion Criteria
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How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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