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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
Sponsor
Scynexis, Inc.
Phase
Observational
Started
2022-07-28
Last updated
2024-07-17

Condition(s) studied

Vulvovaginal 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

Sex
FEMALE
Min age
0 Years
Max age
Healthy volunteers
Accepted
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)

Trial sites (1)

FacilityCityRegionStatus
AWINSA New Delhi Vasant Vihar 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