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NCT04058353 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 271
- Enrollment target
NCT04058353: Completed Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
NCT04058353 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 271 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04058353, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 271 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety 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 F508del and a gating or residual function mutation (F/G and F/RF genotypes).
Primary Outcome
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration.
Interventions
- DRUG IVA
- DRUG TEZ/IVA
- DRUG ELX/TEZ/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 271 participants |
| Start Date | 2019-08-28 |
| Est. Completion | 2020-06-12 |
| Phase | Phase 3 |
What the finished NCT04058353 record still lists
NCT04058353 is an interventional study that assigns participants to a tested intervention. The registered 271 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which IVA is the first listed.
NCT04058353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04058353 about?
NCT04058353 is a clinical study titled "A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)". This study will evaluate the efficacy, safety 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 F508del and a gating or residual function mutation (F/G and F/RF genotyp...
What is the current status of trial NCT04058353?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 271 participants. The study started on 2019-08-28. Estimated completion is 2020-06-12.
What interventions are being tested in trial NCT04058353?
The interventions under investigation include: IVA (DRUG), TEZ/IVA (DRUG), ELX/TEZ/IVA (DRUG).
Who is sponsoring clinical trial NCT04058353?
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 NCT04058353's enrollment target sits among peer trials
271 1216th of 2000 higher than 784 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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