Clinical trial NCT04940533: Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers
Official title: Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cystic Fibrosis
Pregnancy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult females receiving cystic fibrosis transmembrane conductance regulator (CFTR) modulation therapy who are pregnant or breastfeeding.

Brief summary: This study aims to evaluate the pharmacokinetic changes during pregnancy, postpartum, and in breast milk in cystic fibrosis patients receiving a cystic fibrosis transmembrane conductance regulator (CTFR) modulator, including Elexacaftor, Tezacaftor, Ivacaftor, or Lumacaftor.

Detailed description: The advent of cystic fibrosis transmembrane conductance regulator (CFTR) therapy has significantly increased the life expectancy for individuals with cystic fibrosis (CF).

As a result, adults with CF are more likely to have families than they have in the past.

Although the overall pregnancy rate among women with CF age 18-44 is declining (mirroring trends in the general population), the overall number of pregnancies is increasing due to the increasing number of adults with CF. However, little is known about CFTR modulator use in pregnant or breastfeeding mothers, as outlined in a recent review of CF-therapies in pregnant and breastfeeding women. Presently, there is one report of an uncomplicated pregnancy during ivacaftor use, and one case of a successful pregnancy in a woman who was maintained on lumacaftor/ivacaftor with reported maternal and fetal drug levels. In this study, we aim to study the pharmacokinetics of CFTR modulators in pregnancy as well as while breastfeeding.

This information will hopefully improve counseling while offering them for CF patients given the tremendous improvements seen in non-pregnant adults.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in levels of CTFR modulator in blood
timeFrame: approximately 9 months
measure: Change in levels of CTFR modulator in breast milk
timeFrame: 4 days
measure: Change in levels of CTFR modulator in umbilical cord blood
timeFrame: at birth of the infant
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jagadish Patil, MD
role: PRINCIPAL_INVESTIGATOR
References: