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NCT05734521 · ClinicalTrials.gov registry record

Avalglucosidase Alfa Pregnancy Study

A clinical trial of Pregnancy and Pompe Disease, sponsored by Sanofi.

Recruiting
Registry status
100
Enrollment target
1
Study location

NCT05734521: Recruiting study of Pregnancy and Pompe Disease, sponsored by Sanofi.

NCT05734521 is a study of Pregnancy and Pompe Disease that is actively recruiting participants, run by Sanofi. The registered enrollment target is 100 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05734521, a study of Pregnancy and Pompe Disease, is actively recruiting participants, sponsored by Sanofi.

RECRUITING
Registry status
100 participants
Enrollment target
1
Study location

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.

Primary Outcome

Prevalence of pregnancy/labor/delivery/postpartum maternal complications

Conditions Studied

Pregnancy Pompe Disease

Interventions

  • BIOLOGICAL avalglucosidase alfa-NGPT (GZ402666) IV
  • BIOLOGICAL avalglucosidase alfa-NGPT (GZ402666)

Study Locations (1)

New Jersey

  • Investigational site worldwide - Bridgewater

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2022-10-26
Est. Completion 2032-10-31
Sanofi

713 total trials

What NCT05734521 shows while recruiting

NCT05734521 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (89% lower).

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.

NCT05734521 reports a single indexed study location in New Jersey.

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.

What interventions are being tested in trial NCT05734521?

The interventions under investigation include: avalglucosidase alfa-NGPT (GZ402666) IV (BIOLOGICAL), avalglucosidase alfa-NGPT (GZ402666) (BIOLOGICAL).

Who is sponsoring clinical trial NCT05734521?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Pregnancy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05734521's enrollment target sits among peer trials

100 117th of 191 higher than 72 of 191 other Pregnancy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05734521

Source: ClinicalTrials.gov NCT05734521, the US trial registry maintained by the National Library of Medicine. NCT05734521 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.