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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 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 271 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04058353
The ClinicalTrials.gov registry entry for NCT04058353 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 271 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 IVA is the first listed.
NCT04058353 reports 0 study locations.
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.
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