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NCT03633526 · ClinicalTrials.gov registry record · Phase 3
Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Terminated
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT03633526 is a Phase 3 study that was terminated before completion, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 18 participants.
The verdict
NCT03633526, a Phase 3 study, was terminated before completion, sponsored by Vertex Pharmaceuticals Incorporated.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes. The study was discontinued after completion of Part A due to Sponsor's discretion.
Interventions
- DRUG IVA
- DRUG VX-659/TEZ/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2018-08-03 |
| Est. Completion | 2019-01-18 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03633526
The ClinicalTrials.gov registry entry for NCT03633526 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 18 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.
NCT03633526 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03633526 about?
NCT03633526 is a clinical study titled "Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age". This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-659, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects with F/F or F/MF genotypes. The study was discontinued after complet...
What is the current status of trial NCT03633526?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2018-08-03. Estimated completion is 2019-01-18.
What interventions are being tested in trial NCT03633526?
The interventions under investigation include: IVA (DRUG), VX-659/TEZ/IVA (DRUG).
Who is sponsoring clinical trial NCT03633526?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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