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Observational Study of CFTR Modulators in Pregnant and Breastfeeding Individuals

This study is looking at how medications for cystic fibrosis (CFTR modulators like Elexacaftor, Tezacaftor, Ivacaftor, or Lumacaftor) behave in the bodies of pregnant individuals and breastfeeding mothers with cystic fibrosis. Researchers want to understand how the levels of these medications change in your blood during pregnancy, in your breast milk, and in your baby's umbilical cord blood at birth. This information will help doctors better advise CF patients who are pregnant or planning to breastfeed. The study aims to enroll 30 women who are 18 years or older, have cystic fibrosis, and are taking a CFTR modulator during pregnancy and postpartum. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will watch and collect information without giving any new treatments. It aims to enroll 30 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Levels of the medication will be measured in your blood around 9 months of pregnancy, in breast milk at 4 days postpartum, and in umbilical cord blood at birth.

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NCT04940533

Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers

Not Yet Recruiting
Not specifiedAges 18+Observational
University of Minnesota
~30 participants
Updated 2026-01-20 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in levels of CTFR modulator in blood
Measured over approximately 9 months
+2 more outcomes measured

Conditions

Cystic Fibrosis
Pregnancy

Explore related trials

Cystic Fibrosis

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Jagadish Patil, MD · PRINCIPAL_INVESTIGATOR · University of Minnesota

Who to contact

Sabrina Burn, MD
[email protected]
612-301-340
Email the study team

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Eligibility criteria

Inclusion

Female 18 years of age and older
Female who has a diagnosis of cystic fibrosis
Female who is taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum

Exclusion

Female \< 18 years of age
Female with cystic fibrosis who is not taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum
Participant has contraindication to breastfeeding or not planning to breastfeed

What this trial measures

  • Change in levels of CTFR modulator in bloodapproximately 9 months

    Quantification of CTFR modulator in blood will be performed using Liquid Chromatography-Mass Spectrometry (LC-MS) and reported in units of ng/kg. Blood will be collected every 3 months during pregnancy and at the sampling of breast milk 0-4 days after giving birth.

  • Change in levels of CTFR modulator in breast milk4 days

    Quantification of CTFR modulator in blood will be performed using Liquid Chromatography-Mass Spectrometry (LC-MS) and reported in units of ng/ml. Breast milk will be collected following feeding of the infant 0-4 days following birth of the infant.

  • Change in levels of CTFR modulator in umbilical cord bloodat birth of the infant

    Quantification of CTFR modulator in blood will be performed using Liquid Chromatography-Mass Spectrometry (LC-MS) and reported in units of ng/kg. Umbilical cord blood will be collected once at the time the infant is born.