Cystic FibrosisNCT04940533
Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers
An observational study of Cystic Fibrosis and Pregnancy, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cystic Fibrosis, Pregnancy
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to 1 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Adult females receiving cystic fibrosis transmembrane conductance regulator (CFTR) modulation therapy who are pregnant or breastfeeding.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
Kathine Jacobs, DO
Sabrina Burn, MD
About this study
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.
Read the 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
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving CFTR modulator therapy - Trikafta | This is a single arm study. Participants in this study are receiving CFTR modulator therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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/kg. Blood will be collected every 3 months during pregnancy and at the sampling of breast milk 0-4 days after giving birth.
Measured: approximately 9 months
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/ml. Breast milk will be collected following feeding of the infant 0-4 days following birth of the infant.
Measured: 4 days
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/kg. Umbilical cord blood will be collected once at the time the infant is born.
Measured: at birth of the infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jagadish Patil, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04940533
- Sponsor's protocol ID
- PACCS-2020-28860-1
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2021
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers
- ClinicalTrials.gov ID
- NCT04940533
- Acronym / sponsor ID
- PACCS-2020-28860-1
- Conditions
- Cystic Fibrosis, Pregnancy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 25 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving CFTR modulator therapy - Trikafta | – | –This is a single arm study. Participants in this study are receiving CFTR modulator therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult females receiving cystic fibrosis transmembrane conductance regulator (CFTR) modulation therapy who are pregnant or breastfeeding.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in levels of CTFR modulator in blood
Time frame: approximately 9 months
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.
Change in levels of CTFR modulator in breast milk
Time frame: 4 days
Quantification of CTFR modulator in blood will be performed using Liquid Chromatography-Mass Spectrometry (LC-MS) and reported in units of ng/ml. Breast milk will be collected following feeding of the infant 0-4 days following birth of the infant.
Change in levels of CTFR modulator in umbilical cord blood
Time frame: at birth of the infant
Quantification of CTFR modulator in blood will be performed using Liquid Chromatography-Mass Spectrometry (LC-MS) and reported in units of ng/kg. Umbilical cord blood will be collected once at the time the infant is born.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jagadish Patil, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis and Pregnancy, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabrina Burn, MD (612-301-340, burn@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in levels of CTFR modulator in blood (time frame: approximately 9 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.