Observing the effects of CFTR modulators in pregnant women with cystic fibrosis and their newborns
Official title: Monitoring of Women and Children Exposed to the Combination of Elexacaftor-tezacaftor-ivacaftor During Bregnancy and Through Mother's Own Milk.
Run by Region Stockholm · NCT06302270 · Data updated 2026-11-12
This study looks at how CFTR modulators affect pregnant women with cystic fibrosis and their newborns to see if the treatment impacts their health and the babies’ health, including any effects from breast milk.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 50 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Region Stockholm Government |
| Locations | 1 site (Stockholm) |
| Status | Recruiting |
| Started | March 15, 2024 |
| Main results expected | January 31, 2034 |
| Study ends | January 31, 2039 |
| Registry record updated | March 8, 2024 |
| Trial ID | NCT06302270 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pregnant women with cystic fibrosis who are being treated with Kaftrio.
✕Probably not a fit
Patients who are not pregnant or those with cystic fibrosis not receiving CFTR modulators will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on women with cystic fibrosis who are treated with CFTR modulators during pregnancy and the postpartum period. It aims to register maternal health parameters and assess the effects of CFTR modulators on newborn infants, including any impacts from exposure through breast milk. The study will gather data to better understand the implications of CFTR modulator treatment in this unique population.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effects of CFTR modulators during pregnancy, potentially improving maternal and infant health outcomes.
How similar studies have gone: While there may be limited data on this specific population, other studies on CFTR modulators have shown promising results in managing cystic fibrosis, indicating potential for success in this observational approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Woman with cystic fibrosis who is pregnant and treated with Kaftrio. Newborn infant to the above mentioned woman Exclusion Criteria: none
Where it's running
-
Stockholm CF center
Stockholm, Sweden Recruiting
Study contacts
- Study coordinator: jenny svedenkrans
- Email: jenny.svedenkrans@regionstockholm.se
- Phone: +46 8 123 80000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.