Last updated: 09/21/2026 07:01:32
Safety of pregnant subjects exposed to Ibrexafungerp including infant outcomes
GSK study ID
222030
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Ongoing
Ongoing
Trial overview
Official title: A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year
Trial description: This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Major Structural Defects
Timeframe: From Brexafemme exposure up to one year after birth
Secondary outcomes:
To collect and describe pregnancy outcomes
Timeframe: From Brexafemme exposure up to one year post birth
Interventions:
Other: Non-interventional study
Enrollment:
100
Primary completion date:
2029-31-07
Observational study model:
Case-Only
Time perspective:
Other
Clinical publications:
Not applicable
Medical condition
Vulvovaginitis, Candidal
Product
Not applicable
Collaborators
Not applicable
Study date(s)
November 2025 to July 2029
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female
Age
0+ years
Accepts healthy volunteers
Yes
- 1. Exposure to ibrexafungerp during pregnancy or if conception is estimated to have
- occurred within 4 days of the last dose of ibrexafungerp
- 1. Females who were not exposed to safety study medications during pregnancy
- 2. Refusal to participate in the study
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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
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
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Ongoing
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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