Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02390219
The ClinicalTrials.gov registry entry for NCT02390219 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (74% lower). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.
-
Assessing Tenapanor as a Treatment of CF-related Constipation.
RECRUITING · Phase 3
-
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
RECRUITING · Phase 3
-
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
ACTIVE NOT RECRUITING · Phase 3
-
Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
COMPLETED · Phase 3
-
Study of Ataluren (PTC124™) in Cystic Fibrosis
COMPLETED · Phase 3
-
OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis
COMPLETED · Phase 3
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.