Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes

Vulvovaginal Candidiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05908682
• Other study ID #: SCY-078-401
• Status: Recruiting
• Start date: July 28, 2022
• Est. completion date: October 31, 2029

Study information

• Verified date: June 2023
• Source: Scynexis, Inc.
• Contact: Sanjeev Miglani, MD
• Phone: +91-9910533655
• Email: sanjeev.miglani[@]awinsals.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2029
• Est. primary completion date: October 31, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 0 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Candida Infection
• Candidiasis
• Candidiasis, Vulvovaginal
• Vaginal Candidiasis
• Vulvovaginal Candidiasis

Intervention

Other:
• Non-interventional study
This is not an interventional study

Locations

Country	Name	City	State
India	AWINSA	New Delhi	Vasant Vihar

Sponsors (2)

Lead Sponsor	Collaborator
Scynexis, Inc.	AWINSA

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major Structural Defects	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	From Brexafemme exposure up to one year after birth
Secondary	To collect and describe pregnancy outcomes	Live birth, spontaneous abortions, stillbirths, elective abortions, and preterm births	From Brexafemme exposure up to one year post birth