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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 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.

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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.

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

Sponsor

Sanofi

713 total trials

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What the Registry Record Tells You About NCT05734521

The ClinicalTrials.gov registry entry for NCT05734521 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (89% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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