NCT05908682

Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes

A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Scynexis, Inc. · Industry
• Sex: Female
• Age: 0 Years
• Healthy volunteers: Accepted

Summary

This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.

Detailed description

This is a single-arm safety study which comprises an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age who were exposed to ibrexafungerp during pregnancy, or whose conception is estimated to have occurred within four days after receiving last dose of ibrexafungerp, and are volunteering to take part in this study. Subjects will be monitored starting from exposure during pregnancy until one year after live delivery. Information on pregnancy outcomes and complications as well as fetal/neonatal/infant outcomes will be collected during the timeframe described in the protocol. Subjects can enroll in the study by calling the telephone number directly (1-888-982-7299) or through SCYNEXIS BREXAFEMME Pregnancy Study Webpage, OR her healthcare provider (HCP) can, with her consent, enroll her on her behalf. Data will be collected both retrospectively and prospectively using a variety of questionnaire that will be completed by the representative based on interview with the subject and/or HCP

Conditions

• Vulvovaginal Candidiasis
• Candida Infection
• Vaginal Candidiasis

Interventions

Type	Name	Description
OTHER	Non-interventional study	This is not an interventional study

Timeline

• Start date: 2022-07-28
• Primary completion: 2029-10-31
• Completion: 2029-10-31
• First posted: 2023-06-18
• Last updated: 2024-07-17

Locations

1 site across 1 country: India