NCT07148739 Ensuring Access to Optimal Therapy in CF: The ENACT Study
| NCT ID | NCT07148739 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Arkansas Children's Hospital Research Institute |
| Condition | Cystic Fibrosis (CF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 95 participants |
| Start Date | 2025-06-10 |
| Primary Completion | 2030-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 95 participants in total. It began in 2025-06-10 with a primary completion date of 2030-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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).
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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
Contact & Investigator
Jennifer S Guimbellot, Medical Degree and License
PRINCIPAL INVESTIGATOR
Arkansas Children's Hospital Research Institute
Frequently Asked Questions
Who can join the NCT07148739 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07148739 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07148739 currently recruiting?
Yes, NCT07148739 is actively recruiting participants. Contact the research team at jguimbellot@uams.edu for enrollment information.
Where is the NCT07148739 trial being conducted?
This trial is being conducted at Little Rock, United States, Seattle, United States.
Who is sponsoring the NCT07148739 clinical trial?
NCT07148739 is sponsored by Arkansas Children's Hospital Research Institute. The principal investigator is Jennifer S Guimbellot, Medical Degree and License at Arkansas Children's Hospital Research Institute. The trial plans to enroll 95 participants.