Clinical Trials in India / NCT05908682
Recruiting
Observational
Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
NCT05908682 · tracked via the Priya Life Science India tracker
Condition(s) studied
Vulvovaginitis, CandidalVulvovaginal CandidiasisCandida InfectionVaginal Candidiasis
Investigational drug(s) / intervention(s)
Non-interventional study
Non-interventional study: This is not an interventional study
Study summary
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
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
Primary outcome measure(s)
- 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| AWINSA | New Delhi | Vasant Vihar | Recruiting |
More GlaxoSmithKline trials in India
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Active, not recruiting
Phase 2b Study of GSK4532990 in Adults With NASH
Active, not recruiting
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05908682 on ClinicalTrials.gov ↗ ← All trials in India