CFTR Modulators in Pregnancy and Postpartum
Recruiting
- Conditions
- Cystic Fibrosis
- Registration Number
- NCT06302270
- Lead Sponsor
- Region Stockholm
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman
Exclusion Criteria
none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Health effects in the newborn infant 6 years
- Secondary Outcome Measures
Name Time Method
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the effects of elexacaftor-tezacaftor-ivacaftor on CFTR protein function in cystic fibrosis patients during pregnancy?
How does the combination of elexacaftor-tezacaftor-ivacaftor compare to standard-of-care therapies for cystic fibrosis in pregnant women?
Are there specific biomarkers that can predict maternal and fetal outcomes in cystic fibrosis patients using CFTR modulators during pregnancy?
What are the potential adverse events associated with elexacaftor-tezacaftor-ivacaftor exposure in utero and through mother's own milk in cystic fibrosis infants?
What is the role of CFTR modulator combinations like elexacaftor-tezacaftor-ivacaftor in the broader therapeutic landscape for cystic fibrosis, particularly in relation to other drug classes such as potentiators and correctors?
Trial Locations
- Locations (1)
Stockholm CF center
🇸🇪Stockholm, Sweden
Stockholm CF center🇸🇪Stockholm, SwedenTerezia Pinzikova, MD, PhDContact+46 8 123 80000jenny.svedenkrans@regionstockholm.se