Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes

Scynexis

Status: Enrolling

Conditions: Candida Infection; Vaginal Candidiasis; Vulvovaginal Candidiasis

Treatments: Other: Non-interventional study

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT05908682

SCY-078-401

Details and patient eligibility

About

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

Full 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

Enrollment: 100 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Study Cohort

Description:

Subjects who have been treated with Brexafemme (Ibrexafungerp) at any time during pregnancy or whose conception is estimated to have occurred within four days after receiving the last dose of Brexafemme.

Treatment:

Other: Non-interventional study