| NCT ID | NCT00567073 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Genzyme, a Sanofi Company |
| Condition | Glycogen Storage Disease Type II (GSD-II) |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2007-06-18 |
| Primary Completion | 2034-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2007-06-18 with a primary completion date of 2034-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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-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
Contact & Investigator
Trial Transparency email recommended (Toll free number for US & Canada)
✉ Contact-us@sanofi.com📞 800-633-1610
Study Director
STUDY DIRECTOR
Genzyme, a Sanofi Company
Frequently Asked Questions
Who can join the NCT00567073 clinical trial?
This trial is open to female participants only, studying Glycogen Storage Disease Type II (GSD-II). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT00567073 currently recruiting?
Yes, NCT00567073 is actively recruiting participants. Contact the research team at Contact-us@sanofi.com for enrollment information.
Where is the NCT00567073 trial being conducted?
This trial is being conducted at Phoenix, United States, Jacksonville, United States, Atlanta, United States, Indianapolis, United States and 11 additional locations.
Who is sponsoring the NCT00567073 clinical trial?
NCT00567073 is sponsored by Genzyme, a Sanofi Company. The principal investigator is Study Director at Genzyme, a Sanofi Company. The trial plans to enroll 20 participants.