Non-interventional study: This is not an interventional study
Study summary
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
Eligibility
Sex
FEMALE
Min age
0 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
1. Exposure to ibrexafungerp during pregnancy or if conception is estimated to have occurred within 4 days of the last dose of ibrexafungerp
2. Subject and/or parent/legal representative consents to participate and agrees to the conditions and requirements of the study including the interview schedule/completion of questionnaire and release of medical records
* Subject can be identified by the sponsor or HCP, in terms of confirmed pregnancy.
A self-reported pregnancy will be considered as confirmed pregnancy if the Urine Pregnancy Test (UPT) result is positive.
* A woman can self-enroll in the study or her healthcare provider (HCP), with her consent, can enroll her on her behalf.
Exclusion Criteria:
1. Females who were not exposed to safety study medications during pregnancy
2. Refusal to participate in the study
3. An inability to provide an accurate medical history or give informed consent
Primary outcome measure(s)
Major Structural Defects — From Brexafemme exposure up to one year after birth To collect and describe selected fetal/neonatal/infant outcomes (i.e., major and minor congenital malformations, small for gestational age, and postnatal growth and development) at birth and through up to the first year of life of infants born to women exposed to ibrexafungerp during the defined pregnancy exposure window
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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