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NCT05033080 · ClinicalTrials.gov registry record · Phase 3
A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 435
- Enrollment target
NCT05033080 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 435 participants.
The verdict
NCT05033080, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 435 participants
- Enrollment target
Study Summary
The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
Interventions
- DRUG VX-121/TEZ/D-IVA
- DRUG IVA
- DRUG ELX/TEZ/IVA
- DRUG Placebo (matched to VX-121/TEZ/D-IVA)
- DRUG Placebo (matched to ELX/TEZ/IVA)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 435 participants |
| Start Date | 2021-09-14 |
| Est. Completion | 2023-11-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05033080
The ClinicalTrials.gov registry entry for NCT05033080 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 435 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 5 interventions - of which VX-121/TEZ/D-IVA is the first listed.
NCT05033080 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05033080 about?
NCT05033080 is a clinical study titled "A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)". The purpose of this study evaluates the efficacy and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants who were heterozygous for F508del and a minimal function mutation (F/MF participants).
What is the current status of trial NCT05033080?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 435 participants. The study started on 2021-09-14. Estimated completion is 2023-11-21.
What interventions are being tested in trial NCT05033080?
The interventions under investigation include: VX-121/TEZ/D-IVA (DRUG), IVA (DRUG), ELX/TEZ/IVA (DRUG), Placebo (matched to VX-121/TEZ/D-IVA) (DRUG), Placebo (matched to ELX/TEZ/IVA) (DRUG).
Who is sponsoring clinical trial NCT05033080?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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