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NCT04235140 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation
A Phase 3 study, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
NCT04235140 is a Phase 3 study that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 52 participants.
The verdict
NCT04235140, a Phase 3 study, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is a Phase 3, multicenter, open-label and roll-over study in participants who are 12 to \<24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.
Interventions
- DRUG LUM/IVA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-02-24 |
| Est. Completion | 2023-08-22 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04235140
The ClinicalTrials.gov registry entry for NCT04235140 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 52 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 1 intervention - of which LUM/IVA is the first listed.
NCT04235140 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04235140 about?
NCT04235140 is a clinical study titled "Long-term Safety of Lumacaftor/Ivacaftor in Participants With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation". This is a Phase 3, multicenter, open-label and roll-over study in participants who are 12 to \<24 months of age at initiation of Lumacaftor/Ivacaftor (LUM/IVA) treatment.
What is the current status of trial NCT04235140?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2020-02-24. Estimated completion is 2023-08-22.
What interventions are being tested in trial NCT04235140?
The interventions under investigation include: LUM/IVA (DRUG).
Who is sponsoring clinical trial NCT04235140?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
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