Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes

Launched by SCYNEXIS, INC. · Jun 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety of a medication called ibrexafungerp in pregnant women and how it may affect their babies. The trial is currently looking for pregnant women of any age who have taken ibrexafungerp during their pregnancy, or who may have conceived shortly after their last dose. Participants will need to agree to take part in the study, which includes answering questions and allowing access to their medical records.

To be eligible, women must have been exposed to ibrexafungerp while pregnant, and they can either sign up themselves or have their healthcare provider enroll them with their permission. Women who have not taken the medication, refuse to participate, or cannot provide their medical history won't be able to join the study. Those who do participate will help researchers understand how this medication affects both mothers and their infants, contributing valuable information to improve care for future patients.

Gender

FEMALE

Eligibility criteria

• 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