[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04940533":3,"trial-entities:NCT04940533":83,"trial-summary:NCT04940533":86},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":24,"interventions":27,"primary_outcomes":28,"secondary_outcomes":41,"sex":42,"minimum_age":43,"maximum_age":22,"healthy_volunteers":14,"eligibility_criteria":44,"std_ages":54,"locations":57,"central_contacts":73,"overall_officials":77,"references":81,"see_also_links":82},"NCT04940533","PACCS-2020-28860-1","Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers","NOT_YET_RECRUITING","2028-07-01","2026-01","2026-01-20","2027-01-01","University of Minnesota","OTHER",false,"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.","The advent of cystic fibrosis transmembrane conductance regulator (CFTR) therapy has significantly increased the life expectancy for individuals with cystic fibrosis (CF).\n\nAs a result, adults with CF are more likely to have families than they have in the past.\n\nAlthough 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\u002Fivacaftor 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.\n\nThis information will hopefully improve counseling while offering them for CF patients given the tremendous improvements seen in non-pregnant adults.",[18,19],"Cystic Fibrosis","Pregnancy",[],"OBSERVATIONAL",null,[],{"count":25,"type":26},30,"ESTIMATED",[],[29,33,37],{"measure":30,"description":31,"timeFrame":32},"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\u002Fkg. 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",{"measure":34,"description":35,"timeFrame":36},"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\u002Fml. Breast milk will be collected following feeding of the infant 0-4 days following birth of the infant.","4 days",{"measure":38,"description":39,"timeFrame":40},"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\u002Fkg. Umbilical cord blood will be collected once at the time the infant is born.","at birth of the infant",[],"FEMALE","18 Years",{"inclusion":45,"exclusion":49,"raw_text":53},[46,47,48],"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",[50,51,52],"Female \\\u003C 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","Inclusion Criteria:\n\n* Female 18 years of age and older\n* Female who has a diagnosis of cystic fibrosis\n* Female who is taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum\n\nExclusion Criteria:\n\n* Female \\\u003C 18 years of age\n* Female with cystic fibrosis who is not taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum\n* Participant has contraindication to breastfeeding or not planning to breastfeed",[55,56],"ADULT","OLDER_ADULT",[58],{"facility":12,"city":59,"state":60,"zip":61,"country":62,"contacts":63,"geoPoint":70},"Minneapolis","Minnesota","55455","United States",[64,67],{"name":65,"role":66},"Kathine Jacobs, DO","CONTACT",{"name":68,"role":69},"Sabrina Burn, MD","SUB_INVESTIGATOR",{"lat":71,"lon":72},44.97997,-93.26384,[74],{"name":68,"role":66,"phone":75,"email":76},"612-301-340","burn@umn.edu",[78],{"name":79,"affiliation":12,"role":80},"Jagadish Patil, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":84,"biomarkers":85},[18],[],{"nct_id":4,"found":87,"summary":88,"prompt_version":98},true,{"design":89,"status":90,"heading":91,"summary":92,"follow_up":93,"word_count":94,"commitments":95,"compensation":96,"drugs_mentioned":97},"This is an observational study, meaning researchers will watch and collect information without giving any new treatments. It aims to enroll 30 participants.","completed","Observational Study of CFTR Modulators in Pregnant and Breastfeeding Individuals","This study is looking at how medications for cystic fibrosis (CFTR modulators like Elexacaftor, Tezacaftor, Ivacaftor, or Lumacaftor) behave in the bodies of pregnant individuals and breastfeeding mothers with cystic fibrosis. Researchers want to understand how the levels of these medications change in your blood during pregnancy, in your breast milk, and in your baby's umbilical cord blood at birth. This information will help doctors better advise CF patients who are pregnant or planning to breastfeed. The study aims to enroll 30 women who are 18 years or older, have cystic fibrosis, and are taking a CFTR modulator during pregnancy and postpartum. The current recruitment status is unclear.","Levels of the medication will be measured in your blood around 9 months of pregnancy, in breast milk at 4 days postpartum, and in umbilical cord blood at birth.",108,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]