Status:
RECRUITING
Ensuring Access to Optimal Therapy in CF: The ENACT Study
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cystic Fibrosis (CF)
Eligibility:
All Genders
3+ years
Phase:
PHASE4
Brief Summary
This clinical trial is examining the action and effects of several new drugs in the treatment of cystic fibrosis in children. In addition, several genetic factors are examined. The hope is that the ab...
Detailed Description
Understanding variation in genetic response to pharmacological treatments and personalized CFTR modulator response is crucial to the optimization of the use of these novel compounds; expansion to all ...
Eligibility Criteria
Inclusion
- documentation of CF diagnosis per CFF diagnostic criteria and known CFTR genotype
- age 2 years and older
- ability to provide written informed consent and/or assent (by subject and/or legal guardian)
- on a stable dose of triple combination CFTR modulator therapy for at least two weeks prior to Visit 1
- clinically stable lung disease, defined as no documented acute decrease in FEV1 \> 10%, OR use of additional antibiotics (intravenous \[IV\] or oral \[PO\]) within 4 weeks prior to screening
Exclusion
- recent significant unintentional weight loss, as determined by the investigator, in the 4 weeks prior to screening
- pregnant or breastfeeding female
- history of alcohol or substance abuse in the 6 months prior to screening
- participation in a study involving an investigational intervention within 28 days (or 5 half-lives, whichever is longer) prior to screening
- in the opinion of the Investigator, medical or psychiatric illness, or other conditions that would interfere with participation
Key Trial Info
Start Date :
June 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT07148739
Start Date
June 10 2025
End Date
December 1 2030
Last Update
August 29 2025
Active Locations (2)
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1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72205
2
University of Washington
Seattle, Washington, United States, 72205