Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age0+
SponsorScynexis, Inc.
About this trial
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
Eligibility criteria
Qualifiers
Exposure to ibrexafungerp during pregnancy or if conception is estimated to have occurred within 4 days of the last dose of ibrexafungerp
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 woman can self-enroll in the study or her healthcare provider (HCP), with her consent, can enroll her on her behalf.
Disqualifiers
Females who were not exposed to safety study medications during pregnancy
Refusal to participate in the study
An inability to provide an accurate medical history or give informed consent
Trial design
Treatments tested in this trial
- Non-interventional study
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Scynexis, Inc.
Lead sponsor
AWINSA
Collaborator
Source ClinicalTrials.gov