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NCT Number: NCT05908682

Safety of Pregnant Subjects Exposed to Ibrexafungerp Including Infant Outcomes

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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Key information

Conditions

Vulvovaginal Candidiasis Bacterial Infections and Mycoses Candida Infection Candidiasis Candidiasis, Oral Candidiasis, Vulvovaginal Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Infections Mouth Diseases Mycoses Stomatognathic Diseases Urogenital Diseases Vaginal Candidiasis Vaginal Diseases Vaginitis Vulvar Diseases Vulvitis Vulvovaginitis

Age range

0 year and older

Sex eligibility

Female

Study type

Observational

Primary location

AWINSA

New Delhi, Vasant Vihar, 110057, India

Location status: Recruiting

Location contact

Sanjeev Miglani, MD

CONTACT

[email protected]

+91-9910533655

Sanjeev Miglani, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

This is not an interventional study

Primary outcomes

  1. 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

  1. To collect and describe pregnancy outcomes

    Time frame: From Brexafemme exposure up to one year post birth

    Live birth, spontaneous abortions, stillbirths, elective abortions, and preterm births

Study contacts

Contact information is provided by the study sponsor or research team.

Sanjeev Miglani, MD

CONTACT

[email protected]

+91-9910533655

Sponsors and collaborators

Lead sponsor

Scynexis, Inc.

Industry

Collaborators

  • AWINSA

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Jun 18, 2023
Registry last updated
Jul 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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