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NCT03506061 · ClinicalTrials.gov registry record · Phase 2
Trikafta in Cystic Fibrosis Patients
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
NCT03506061 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 42 participants.
The verdict
NCT03506061, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
Study Summary
This clinical study will enroll 42 participants without the F508del mutation, carrying partial function or N1303K mutations not approved for Trikafta, and who are not expected to be approved for CFTR modulator treatment in the immediate future. Each participant will be given Trikafta for approximately four weeks. The study researchers will monitor clinical endpoints that include forced expiratory volume (FEV1) and sweat chloride. Additionally, the researchers will obtain skin biopsy material and/or blood sample from each subject so that induced pluripotent stem (iPS) cells can be modified into airway cell monolayers and tested for response to Trikafta. In this way, the study will evaluate an emerging and readily accessible in vitro endpoint as a predictor of clinical response. This study will serve as a pilot/test case for other clinical protocols relevant to patients with rare CFTR variants who do not currently receive modulator therapies.
Interventions
- DRUG Trikafta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2024-02-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03506061
The ClinicalTrials.gov registry entry for NCT03506061 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 42 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Trikafta is the first listed.
NCT03506061 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03506061 about?
NCT03506061 is a clinical study titled "Trikafta in Cystic Fibrosis Patients". This clinical study will enroll 42 participants without the F508del mutation, carrying partial function or N1303K mutations not approved for Trikafta, and who are not expected to be approved for CFTR modulator treatment in the immediate future. Each participant will be given Trikafta for approximate...
What is the current status of trial NCT03506061?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2019-09-04. Estimated completion is 2024-02-13.
What interventions are being tested in trial NCT03506061?
The interventions under investigation include: Trikafta (DRUG).
Who is sponsoring clinical trial NCT03506061?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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