Health TrialsbyHealthPanel

A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding

ConditionFabry Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
AgeNot listed
SponsorAmicus Therapeutics

About this trial

This is a global prospective observational study of women with Fabry disease and their infants during pregnancy and/or breastfeeding. The study will evaluate outcomes of pregnancy and/or breastfeeding in women and infants exposed to migalastat.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with Fabry disease who are pregnant and/or breastfeeding, whether or not they are exposed to migalastat

Able and willing to provide informed consent or assent, if applicable.

Able and willing to provide HCP contact information.

Disqualifiers

None

Trial population

Pregnant and/or breastfeeding patients with Fabry disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • migalastat

    Drug

    This is an observational study. Patients as described in Cohort 1 should have been exposed to at least 1 dose of migalastat during pregnancy and/or breastfeeding.

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Cohort 11 intervention
Group B: Cohort 20 interventions

Trial outcomes

Primary outcomes

1

Number of major birth defects

Time frame
Through the pregnancy, an average of 40 weeks and up to 12 months of infant age

Secondary outcomes

1

Incidence of spontaneous abortion

Time frame
: up to 20 weeks
2

Number of elective or induced abortion

Time frame
Through the pregnancy, an average of 40 weeks
3

Number of fetal death or stillbirth

Time frame
Greater than 20 weeks of pregnancy and through the pregnancy, average of 40 week
4

Number of live birth

Time frame
at the delivery, an average of 40 weeks of pregnancy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Amicus Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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