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

NCT ID: NCT04940533

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2027-01-01
• Study Completion Date: 2028-07-01

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.

Conditions

Cystic Fibrosis; Pregnancy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants receiving CFTR modulator therapy - Trikafta

This is a single arm study. Participants in this study are receiving CFTR modulator therapy.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jagadish Patil, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Central Contacts

Sabrina Burn, MD

Role: CONTACT

burn@umn.edu

612-301-340

Facility Contacts

Kathine Jacobs, DO

Role: primary

Other Identifiers

PACCS-2020-28860-1

Identifier Type: -

Identifier Source: org_study_id