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NCT04537793 · ClinicalTrials.gov registry record · Phase 3
Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 83
- Enrollment target
NCT04537793 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 83 participants.
The verdict
NCT04537793, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 83 participants
- Enrollment target
Study Summary
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination therapy in CF subjects 2 through 5 years of age.
Interventions
- DRUG IVA
- DRUG ELX/TEZ/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2022-06-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04537793
The ClinicalTrials.gov registry entry for NCT04537793 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which IVA is the first listed.
NCT04537793 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04537793 about?
NCT04537793 is a clinical study titled "Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years". This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination therapy in CF subjects 2 through 5 years of age.
What is the current status of trial NCT04537793?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 83 participants. The study started on 2020-11-19. Estimated completion is 2022-06-03.
What interventions are being tested in trial NCT04537793?
The interventions under investigation include: IVA (DRUG), ELX/TEZ/IVA (DRUG).
Who is sponsoring clinical trial NCT04537793?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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