Actively Recruiting
Ensuring Access to Optimal Therapy in CF: The ENACT Study
Led by Arkansas Children's Hospital Research Institute · Updated on 2025-08-29
95
Participants Needed
2
Research Sites
285 weeks
Total Duration
On this page
Sponsors
A
Arkansas Children's Hospital Research Institute
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 ability to determine prior to treatment those individuals who will or will not respond to existing therapies will avoid needless risk of side effects and the high cost of a potentially ineffective treatment regimen. Understanding the way these drugs work in the body and the best way to study them is critical to expanding the use of these drugs to all patients with cystic fibrosis (CF).
CONDITIONS
Official Title
Ensuring Access to Optimal Therapy in CF: The ENACT Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of cystic fibrosis according to CFF diagnostic criteria with known CFTR genotype
- Age 2 years or older
- Ability to provide written informed consent and/or assent by participant or legal guardian
- On a stable dose of triple combination CFTR modulator therapy for at least two weeks before Visit 1
- Clinically stable lung disease without acute FEV1 decrease over 10% or recent additional antibiotic use within 4 weeks before screening
You will not qualify if you...
- Recent significant unintentional weight loss in the 4 weeks before screening
- Pregnant or breastfeeding female
- History of alcohol or substance abuse in the 6 months before screening
- Participation in another investigational study within 28 days or 5 half-lives prior to screening
- Medical or psychiatric illness or other conditions that may interfere with participation in the investigator's opinion
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72205
Actively Recruiting
2
University of Washington
Seattle, Washington, United States, 72205
Actively Recruiting
Research Team
J
Jennifer S Guimbellot, Medical Degree and License
CONTACT
M
Michelle Gillespie
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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