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NCT02390219 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease
A Phase 3 study of Cystic Fibrosis and Advanced Lung Disease, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 46
- Enrollment target
- 6
- Study locations
NCT02390219: Completed Phase 3 study of Cystic Fibrosis and Advanced Lung Disease, sponsored by Vertex Pharmaceuticals Incorporated.
NCT02390219 is a Phase 3 study of Cystic Fibrosis and Advanced Lung Disease that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 46 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (74% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02390219, a Phase 3 study of Cystic Fibrosis and Advanced Lung Disease, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 46 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation
Primary Outcome
AE: any untoward medical occurrence in a participant during the study; event does not necessarily have a causal relationship with treatment. This includes any newly occurring event/previous condition that has increased in severity/frequency after informed consent form is signed. AE includes serious as well as non-serious AEs. SAE (subset of AE): medical event, which falls into any of the following categories, regardless of its relationship to study drug: death, life threatening adverse experienc
Conditions Studied
Interventions
- DRUG Ivacaftor
- DRUG Lumacaftor
Study Locations (6)
Colorado
- - Denver
Florida
- - Tampa
Illinois
- - Chicago
Missouri
- - St Louis
Pennsylvania
- - Pittsburgh
Texas
- - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-10 |
| Phase | Phase 3 |
What the finished NCT02390219 record still lists
NCT02390219 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (74% lower).
The record links to 2 conditions, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Ivacaftor is the first listed.
NCT02390219 lists 6 locations in 6 states (Colorado, Florida, Illinois).
Frequently Asked Questions
What is clinical trial NCT02390219 about?
NCT02390219 is a clinical study titled "Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease". The purpose of this study is to evaluate the safety and tolerability of LUM/IVA combination therapy in subjects 12 years and older with CF and advanced lung disease and who are homozygous for the F508del CFTR mutation
What is the current status of trial NCT02390219?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 46 participants. The study started on 2015-03. Estimated completion is 2016-10.
What conditions does trial NCT02390219 study?
This clinical trial studies the following conditions: Cystic Fibrosis, Advanced Lung Disease.
What interventions are being tested in trial NCT02390219?
The interventions under investigation include: Ivacaftor (DRUG), Lumacaftor (DRUG).
Who is sponsoring clinical trial NCT02390219?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02390219 being conducted?
This trial has 6 study locations across Colorado, Florida, Illinois, Missouri, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02390219's enrollment target sits among peer trials
46 93rd of 169 higher than 77 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis 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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