Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes

Sponsor

Scynexis, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05908682

Collaborator

AWINSA (Other)

100

Enrollment

Location

87.1

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vulvovaginal Candidiasis Candida Infection Vaginal Candidiasis	Other: Non-interventional study

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

Jul 28, 2022

Anticipated Primary Completion Date :

Oct 31, 2029

Anticipated Study Completion Date :

Oct 31, 2029

Arms and Interventions

Arm	Intervention/Treatment
Study Cohort 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.	Other: Non-interventional study This is not an interventional study

Arm

Intervention/Treatment

Study Cohort

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.

Other: Non-interventional study

This is not an interventional study

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

To collect and describe pregnancy outcomes [From Brexafemme exposure up to one year post birth]
Live birth, spontaneous abortions, stillbirths, elective abortions, and preterm births

Eligibility Criteria

Criteria

Ages Eligible for Study:

0 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Exposure to ibrexafungerp during pregnancy or if conception is estimated to have occurred within 4 days of the last dose of ibrexafungerp
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