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NCT04058366 · ClinicalTrials.gov registry record · Phase 3
Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 251
- Enrollment target
NCT04058366 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 251 participants.
The verdict
NCT04058366, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 251 participants
- Enrollment target
Study Summary
This study evaluated the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (F/G and F/RF genotypes).
Interventions
- DRUG IVA
- DRUG ELX/TEZ/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 251 participants |
| Start Date | 2019-12-05 |
| Est. Completion | 2022-12-16 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04058366
The ClinicalTrials.gov registry entry for NCT04058366 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 251 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.
NCT04058366 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04058366 about?
NCT04058366 is a clinical study titled "Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy". This study evaluated the long-term safety, efficacy, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for the F508del mutation and a gating or residual function mutation (...
What is the current status of trial NCT04058366?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 251 participants. The study started on 2019-12-05. Estimated completion is 2022-12-16.
What interventions are being tested in trial NCT04058366?
The interventions under investigation include: IVA (DRUG), ELX/TEZ/IVA (DRUG).
Who is sponsoring clinical trial NCT04058366?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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