CFTR Modulators in Pregnancy and Postpartum
Monitoring of Women and Children Exposed to the Combination of Elexacaftor-tezacaftor-ivacaftor During Bregnancy and Through Mother's Own Milk.
1 other identifier
observational
75
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedStudy Start
First participant enrolled
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 31, 2039
March 8, 2024
March 1, 2024
9.9 years
March 4, 2024
March 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Health effects in the newborn infant
6 years
Study Arms (1)
mother-infant dyads
Eligibility Criteria
Woman with cystic fibrosis who is pregnant and treated with Kaftrio and her newborn infant
You may qualify if:
- Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Stockholmlead
- Karolinska Institutetcollaborator
Study Sites (1)
Stockholm CF center
Stockholm, Sweden
Biospecimen
plasma and breastmilk
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2024
First Posted
March 8, 2024
Study Start
March 15, 2024
Primary Completion (Estimated)
January 31, 2034
Study Completion (Estimated)
January 31, 2039
Last Updated
March 8, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share
NO plan to share individual data. Not allowed.