Avalglucosidase Alfa Pregnancy Study

Part of paid clinical trials in Bridgewater, New Jersey.

Sponsor
Sanofi
Study ID
NCT05734521
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • avalglucosidase alfa-NGPT (GZ402666) IV — BIOLOGICAL
    intravenous infusion
  • avalglucosidase alfa-NGPT (GZ402666) — BIOLOGICAL
    exposed via pregnancy and lactation

Study Details

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.

Key Dates

Start date
Oct 26, 2022
Status verified
Jan 2026
Primary completion
Oct 31, 2032
Completion
Oct 31, 2032

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Pregnant women exposed to avalglucosidase alfa
    Pregnant women with a confirmed diagnosis of Pompe disease and avalglucosidase alfa exposure during the pregnancy and/or lactation
  • Arm: Infants born to mother/father exposed to avalglucosidase alfa
    Infants born to mother/father with a confirmed diagnosis of Pompe disease and exposed to avalglucosidase alfa

Primary Outcome Measure

Maternal complications [ Time Frame: through study completion, an average of 10 years ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (1)

FacilityCityStateZIPSite coordinators
Investigational site worldwideBridgewaterNew Jersey08807-

Find similar trials in Bridgewater, NJ

By research site
Investigational· Bridgewater, NJ

Related Studies