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Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes

NCT05908682 — Recruiting, 100 participants, GlaxoSmithKline

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A Single-arm Safety Study of Subjects Exposed to Ibrexafungerp Whilst Pregnant, Including Infant Outcomes Up to One Year

RegistryNCT05908682
StatusRecruiting
Study typeObservational
Enrollment100 (Estimated)
SponsorGlaxoSmithKline (Industry)
ConditionsVulvovaginitis, Candidal, Vulvovaginal Candidiasis, Candida Infection, Vaginal Candidiasis
InterventionsNon-interventional study (Other)
Datesstart 2025-11-12, primary completion 2029-07-31 (estimated), completion 2029-07-31 (estimated), first posted 2023-06-18, last updated 2026-09-23
Locations1 site in India

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-Summary

This is an ongoing evaluation of subjects exposed to ibrexafungerp while pregnant. The study population will include pregnant women of any age.

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+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

+Arms and interventions

ArmTypeInterventionsDescription
Study CohortOther: Non-interventional studySubjects 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.
  • Non-interventional study (Other): This is not an interventional study

+Outcome measures

Primary outcomes

  • Major Structural Defects [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]: Live birth, spontaneous abortions, stillbirths, elective abortions, and preterm births

+Eligibility

Sex: Female, ages: 0 Years to any, accepts healthy volunteers

Inclusion Criteria:

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

   * 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:

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

+Locations (1)

FacilityCityCountryStatus
AWINSANew Delhi, Vasant ViharIndiaRecruiting

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