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

Launched by UNIVERSITY OF MINNESOTA · Jun 17, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how the body processes certain medications used to treat cystic fibrosis during pregnancy and after giving birth. Specifically, it will look at how these medications, known as CFTR modulators (including Elexacaftor, Tezacaftor, Ivacaftor, and Lumacaftor), are affected when taken by pregnant women and how they appear in breast milk for breastfeeding mothers. The goal is to better understand how these treatments work in this unique time of life.

To participate in this study, women must be at least 18 years old, have a diagnosis of cystic fibrosis, and be taking one of the CFTR modulator medications during their pregnancy and after giving birth. Unfortunately, women under 18 or those not using these specific medications during pregnancy will not be eligible. Participants can expect to provide information about their health and medications during the trial, helping researchers gather important data that could improve treatment for future mothers with cystic fibrosis. This study is currently not recruiting participants, but it represents a significant step in understanding the safety and effectiveness of these treatments for pregnant and breastfeeding women.

Gender

FEMALE

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