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Avalglucosidase Alfa Pregnancy Study
NCT05734521 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL avalglucosidase alfa-NGPT (GZ402666) IV
- BIOLOGICAL avalglucosidase alfa-NGPT (GZ402666)
Study Locations (1)
New Jersey
- Investigational site worldwide — Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2022-10-26 |
| Est. Completion | 2032-10-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05734521
The ClinicalTrials.gov registry entry for NCT05734521 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Pregnancy appearing as the primary indexed condition, and to 2 interventions — of which avalglucosidase alfa-NGPT (GZ402666) IV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05734521 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05734521 about?
NCT05734521 is a clinical study titled "Avalglucosidase Alfa Pregnancy Study". 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 ...
What is the current status of trial NCT05734521?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2022-10-26. Estimated completion is 2032-10-31.
What conditions does trial NCT05734521 study?
This clinical trial studies the following conditions: Pregnancy, Pompe Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05734521?
The interventions under investigation include: avalglucosidase alfa-NGPT (GZ402666) IV (BIOLOGICAL), avalglucosidase alfa-NGPT (GZ402666) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05734521?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05734521 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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