NCT04940533Not yet recruiting
Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 17 Jun 2021
- Start date
- 1 Jan 2027
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- University of Minnesota
- Diseases
- Cystic fibrosis
- NCT number
- NCT04940533
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Jan 2027 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Female with cystic fibrosis who is not taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum
Age
- Female \< 18 years of age
Other
- Participant has contraindication to breastfeeding or not planning to breastfeed
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.