Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age0+
SponsorGlaxoSmithKline
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
This trial accepts healthy volunteersQualifiers
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 population
The study population will include women who were exposed to ibrexafungerp at any time during pregnancy or whose conception is estimated to have occurred within four days after receiving last dose of ibrexafungerp, volunteering to take part in this study.
Trial design
Design model
Case-only
Time perspective
Other
Treatments tested in this trial
Non-interventional study
Other interventionThis is not an interventional study
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Study Cohort1 intervention
Trial outcomes
Primary outcomes
1
Major Structural Defects
To collect and describe selected fetal/neonatal/infant outcomes (i.e., major and minor congenital malformations, small for gestational age, and postnatal growth and development) at birth and through up to the first year of life of infants born to women exposed to ibrexafungerp during the defined pregnancy exposure window
Time frame
From Brexafemme exposure up to one year after birthSecondary outcomes
1
To collect and describe pregnancy outcomes
Live birth, spontaneous abortions, stillbirths, elective abortions, and preterm births
Time frame
From Brexafemme exposure up to one year post birthSponsors and contacts
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Source ClinicalTrials.gov