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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04940533
• Other study ID #: PACCS-2020-28860-1
• Status: Not yet recruiting
• Start date: December 1, 2024
• Est. completion date: January 2025

Study information

• Verified date: March 2024
• Source: University of Minnesota
• Contact: Sabrina Burn, MD
• Phone: 612-301-340
• Email: burn[@]umn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Pregnancy

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in levels of CTFR modulator in blood	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.	approximately 9 months
Primary	Change in levels of CTFR modulator in breast milk	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.	4 days
Primary	Change in levels of CTFR modulator in umbilical cord blood	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.	at birth of the infant