Evaluating the safety of ibrexafungerp in pregnant women and their infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Awinsa
  New Delhi, Vasant Vihar, India Recruiting

Study contacts

• Study coordinator: Sanjeev Miglani, MD
• Email: sanjeev.miglani@awinsals.com
• Phone: +91-9910533655

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.