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A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
This is a single-arm safety study which comprises an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age who were exposed to ibrexafungerp during pregnancy, or whose conception is estimated to have occurred within four days after receiving last dose of ibrexafungerp, and are volunteering to take part in this study. Subjects will be monitored starting from exposure during pregnancy until one year after live delivery. Information on pregnancy outcomes and complications as well as fetal/neonatal/infant outcomes will be collected during the timeframe described in the protocol. Subjects can enroll in the study by calling the telephone number directly (1-888-982-7299) or through SCYNEXIS BREXAFEMME Pregnancy Study Webpage, OR her healthcare provider (HCP) can, with her consent, enroll her on her behalf. Data will be collected both retrospectively and prospectively using a variety of questionnaire that will be completed by the representative based on interview with the subject and/or HCP
Age
0 - No limit years
Sex
FEMALE
Healthy Volunteers
Yes
AWINSA
New Delhi, Vasant Vihar, India
Start Date
July 28, 2022
Primary Completion Date
October 31, 2029
Completion Date
October 31, 2029
Last Updated
July 17, 2024
100
ESTIMATED participants
Non-interventional study
OTHER
Lead Sponsor
Scynexis, Inc.
Collaborators
NCT06983041
NCT07303101
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06835361