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NCT03525444 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 405
- Enrollment target
NCT03525444 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 405 participants.
The verdict
NCT03525444, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 405 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).
Interventions
- DRUG Placebo
- DRUG IVA
- DRUG VX-445/TEZ/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 405 participants |
| Start Date | 2018-06-15 |
| Est. Completion | 2019-04-24 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03525444
The ClinicalTrials.gov registry entry for NCT03525444 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 405 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 3 interventions - of which Placebo is the first listed.
NCT03525444 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03525444 about?
NCT03525444 is a clinical study titled "A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)". This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are heterozygous for F508del and a minimal function mutation (F/MF subjects).
What is the current status of trial NCT03525444?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 405 participants. The study started on 2018-06-15. Estimated completion is 2019-04-24.
What interventions are being tested in trial NCT03525444?
The interventions under investigation include: Placebo (DRUG), IVA (DRUG), VX-445/TEZ/IVA (DRUG).
Who is sponsoring clinical trial NCT03525444?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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