Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-interventional study.
- Who it may be relevant to
- Registry conditions: Vulvovaginal Candidiasis, Candida Infection, Vaginal Candidiasis. Basic parameters: from 0 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year
Overview
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
Interventions
- Other Non-interventional study
This is not an interventional study
Primary outcome measures
- Major Structural Defects [Time frame: From Brexafemme exposure up to one year after birth]
Secondary outcome measures (1)
- To collect and describe pregnancy outcomes [Time frame: From Brexafemme exposure up to one year post birth]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-only
Study locations
India · 1 center
- AWINSA — New Delhi
Identifiers
NCT: NCT05908682 · SCY-078-401