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NCT04940533 · ClinicalTrials.gov registry record
Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers
A clinical trial, sponsored by University of Minnesota.
- Not yet
- Registry status
- 30
- Enrollment target
NCT04940533: Clinical Trial study, sponsored by University of Minnesota.
NCT04940533 is a clinical trial that has not yet begun recruiting, run by University of Minnesota. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04940533 has not yet begun recruiting, sponsored by University of Minnesota.
- NOT YET RECRUITING
- Registry status
- 30 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2027-01-01 |
| Est. Completion | 2028-07-01 |
What is known before NCT04940533 opens enrollment
NCT04940533 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT04940533 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04940533 about?
NCT04940533 is a clinical study titled "Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers". 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.
What is the current status of trial NCT04940533?
This trial is currently not yet recruiting. The enrollment target is 30 participants. The study started on 2027-01-01. Estimated completion is 2028-07-01.
Who is sponsoring clinical trial NCT04940533?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
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