Evaluating the safety of ibrexafungerp in pregnant women and their infants
A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year
This study is testing whether ibrexafungerp is safe for pregnant women and their babies by looking at their health during and after pregnancy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 0 Years and up |
| Sex | Female |
| Sponsor | Scynexis, Inc. Industry-sponsored |
| Locations | 1 site (New Delhi, Vasant Vihar) |
| Trial ID | NCT05908682 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on the safety of ibrexafungerp exposure during pregnancy. It includes pregnant women of any age who have been exposed to the medication or conceived shortly after its last dose. Participants will be monitored from the time of exposure through one year after delivery, with data collected on pregnancy outcomes and infant health. The study employs both retrospective and prospective data collection methods, utilizing questionnaires completed by participants or their healthcare providers.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women who have been exposed to ibrexafungerp during their pregnancy or shortly after its administration.
Not a fit: Patients who have not been exposed to ibrexafungerp during pregnancy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of ibrexafungerp for pregnant women and their infants.
How similar studies have performed: While there may be studies on antifungal safety in pregnancy, this specific evaluation of ibrexafungerp is novel and not extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Delhi, Vasant Vihar
- Awinsa — New Delhi, Vasant Vihar, India (Recruiting)
Study contacts
- Study coordinator: Sanjeev Miglani, MD
- Email: sanjeev.miglani@awinsals.com
- Phone: +91-9910533655
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.