Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes

NCT ID: NCT05908682

Last Updated: 2024-07-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-28
• Study Completion Date: 2029-10-31

Brief 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

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

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.

Non-interventional study

Intervention Type: OTHER

This is not an interventional study

Interventions

Non-interventional study

This is not an interventional study

Intervention Type: OTHER

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

• Minimum Eligible Age: 0 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

AWINSA

UNKNOWN

Sponsor Role: collaborator

Scynexis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

AWINSA

New Delhi, Vasant Vihar, India

Site Status: RECRUITING

Countries

India

Central Contacts

Sanjeev Miglani, MD

Role: CONTACT

sanjeev.miglani@awinsals.com

+91-9910533655

Facility Contacts

Sanjeev Miglani, MD

Role: primary

sanjeev.miglani@awinsals.com

+91-9910533655

Other Identifiers

SCY-078-401

Identifier Type: -

Identifier Source: org_study_id