Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06302270

CFTR Modulators in Pregnancy and Postpartum

Observational study on women with Cystic Fibrosis treated with CFTR modulators during pregnancy and postpartum and their children. Registration on maternal health parameters and effects of CFTR-modulators in the newborn infant as well as effects of exposure through mother's own milk.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

Up to 50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman

Exclusion criteria

none

Treatment and study plan

Primary outcomes

  1. Health effects in the newborn infant

    Time frame: 6 years

Study contacts

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

Terezia Pinzikova

CONTACT

+46 8 123 80000

jenny svedenkrans

CONTACT

[email protected]

+46 8 123 80000

Sponsors and collaborators

Lead sponsor

Region Stockholm

Other Gov

Collaborators

  • Karolinska Institutet

Registry information

Official study title

Monitoring of Women and Children Exposed to the Combination of Elexacaftor-tezacaftor-ivacaftor During Bregnancy and Through Mother's Own Milk.

Important dates

Study start
2024
Primary completion
2034
Study completion
2039
First posted
Mar 8, 2024
Registry last updated
Mar 8, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.