Clinical trial Recruiting at 1 site Observational Ages Any age to 50

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.

More Cystic Fibrosis trials

Quick facts

Study typeObservational
AgesAny age to 50 Years
SexAll
Enrollment75 (estimated)
SponsorRegion Stockholm
Government
Locations1 site (Stockholm)
StatusRecruiting
StartedMarch 15, 2024
Main results expectedJanuary 31, 2034
Study endsJanuary 31, 2039
Registry record updatedMarch 8, 2024
Trial IDNCT06302270 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.