Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes

NCT05908682 | Recruiting

• 1 other identifier: SCY-078-401
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Vulvovaginal Candidiasis; Candida Infection; Vaginal Candidiasis

Keywords

VVC; Thrush; BREXAFEMME; Candidiasis; Vaginal Yeast; Yeast Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To collect and describe pregnancy outcomes

  From Brexafemme exposure up to one year post birth

Study Arms (1)

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

Interventions

Non-interventional study OTHER

This is not an interventional study

Study Cohort

Eligibility Criteria

• Age: 0 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include women who were exposed to ibrexafungerp at any time during pregnancy or whose conception is estimated to have occurred within four days after receiving last dose of ibrexafungerp, volunteering to take part in this study.

You may qualify if:

• 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
• 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.

You may not qualify if:

• Females who were not exposed to safety study medications during pregnancy
• Refusal to participate in the study
• An inability to provide an accurate medical history or give informed consent

Sponsors & Collaborators

• Scynexis, Inc.: lead
• AWINSA: collaborator

Study Sites (1)

AWINSA

New Delhi, Vasant Vihar, 110057, India

RECRUITING

MeSH Terms

Conditions

Candidiasis, Vulvovaginal; Candidiasis; Candidiasis, Oral

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Vulvovaginitis; Vaginitis; Vaginal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vulvitis; Vulvar Diseases; Genital Diseases; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Sanjeev Miglani, MD

CONTACT

+91-9910533655; sanjeev.miglani@awinsals.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: July 28, 2022
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)