NCT07148739RecruitingPhase 4
Ensuring Access to Optimal Therapy in CF: The ENACT Study
Ensuring Access to Optimal Therapy in Cystic Fibrosis: The ENACT Study
Source: ClinicalTrials.gov · Last updated 2 Jun 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 2 May 2025
- Start date
- 10 Jun 2025
- Primary completion date
- Dec 2030
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Diseases
- Cystic fibrosis
- NCT number
- NCT07148739
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 100
- From 10 Jun 2025 to the primary completion date, Dec 2030
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- recent significant unintentional weight loss, as determined by the investigator, in the 4 weeks prior to screening
- 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
Other illness
- in the opinion of the Investigator, medical or psychiatric illness, or other conditions that would interfere with participation
Other
- pregnant or breastfeeding female
Who the study is looking for
- 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
Age in the registry: 3 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Recruiting |
| Arkansas Children's Hospital Coordinator of this site? Confirm its status | Little Rock | United States | Recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.