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NCT03691779 · ClinicalTrials.gov registry record · Phase 3
Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 71
- Enrollment target
NCT03691779: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT03691779 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 71 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03691779, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 71 participants
- Enrollment target
Study Summary
This study will evaluate the pharmacokinetics (PK), safety, tolerability, efficacy, and pharmacodynamic effect of VX-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.
Interventions
- DRUG IVA
- DRUG ELX/TEZ/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2018-10-02 |
| Est. Completion | 2020-08-07 |
| Phase | Phase 3 |
What the finished NCT03691779 record still lists
NCT03691779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which IVA is the first listed.
NCT03691779 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03691779 about?
NCT03691779 is a clinical study titled "Evaluation of VX 445/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-445, tezacaftor (TEZ), and ivacaftor (IVA) when dosed in triple combination (TC) in Cystic Fibrosis (CF) subjects 6 through 11 years of age with F/F and F/MF genotypes.
What is the current status of trial NCT03691779?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 71 participants. The study started on 2018-10-02. Estimated completion is 2020-08-07.
What interventions are being tested in trial NCT03691779?
The interventions under investigation include: IVA (DRUG), ELX/TEZ/IVA (DRUG).
Who is sponsoring clinical trial NCT03691779?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03691779's enrollment target sits among peer trials
71 1784th of 2000 higher than 216 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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