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Pompe Pregnancy Sub-Registry

NCT00567073 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2026-04-16

No results posted yet for this study

Summary

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.

Conditions

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

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Study Director · Genzyme, a Sanofi Company

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-18
Primary Completion
2034-01-31
Completion
2034-01-31

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Croatia
  • Czechia
  • Germany
  • Italy
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00567073 on ClinicalTrials.gov