A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- GlaxoSmithKline
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Major Structural Defects
Study Overview
Brief Summary
This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.
Detailed Description
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 0 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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 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
- •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
Arms & Interventions
Study Cohort
Subjects who have been treated with Brexafemme (Ibrexafungerp) at any time during pregnancy or whose conception is estimated to have occurred within four days after receiving the last dose of Brexafemme.
Intervention: Non-interventional study (Other)
Outcomes
Primary Outcomes
Major Structural Defects
Time Frame: From Brexafemme exposure up to one year after birth
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
Secondary Outcomes
- To collect and describe pregnancy outcomes(From Brexafemme exposure up to one year post birth)