| NCT ID | NCT05734521 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sanofi |
| Condition | Pompe Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2022-10-26 |
| Primary Completion | 2032-10-31 |
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 100 participants in total. It began in 2022-10-26 with a primary completion date of 2032-10-31.
⚠ 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 is a worldwide, descriptive safety study collecting data on women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation, to assess the risks of avalglucsodiase alfa on pregnancy and maternal complications and adverse effects in the developing fetus, neonate, and infant. * Outcomes in exposed infants, including growth and development, will be assessed through at least the first year of life. * Data will be collected for approximately 10 years.
Eligibility Criteria
Inclusion Criteria: * Women and their offspring exposed to avalglucosidase alfa during pregnancy and/or lactation for whom an Individual Case Safety Report (ICSR) has been submitted to the Sanofi Global Pharmacovigilance (PV) department, and/or, * Women exposed to avalglucosidase alfa during pregnancy and/or lactation who have provided informed consent to enroll in the Pompe Pregnancy Sub-registry. Exclusion Criteria: There are no exclusion criteria in this study. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Contact & Investigator
Trial Transparency email recommended (Toll free for US & Canada)
✉ Contact-US@sanofi.com📞 800-633-1610
Clinical Sciences & Operations
STUDY DIRECTOR
Sanofi
Frequently Asked Questions
Who can join the NCT05734521 clinical trial?
This trial is open to female participants only, studying Pompe Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05734521 currently recruiting?
Yes, NCT05734521 is actively recruiting participants. Contact the research team at Contact-US@sanofi.com for enrollment information.
Where is the NCT05734521 trial being conducted?
This trial is being conducted at Bridgewater, United States.
Who is sponsoring the NCT05734521 clinical trial?
NCT05734521 is sponsored by Sanofi. The principal investigator is Clinical Sciences & Operations at Sanofi. The trial plans to enroll 100 participants.