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NCT03224351 · ClinicalTrials.gov registry record · Phase 2
A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis
A Phase 2 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 2
- Development phase
- 124
- Enrollment target
- 20
- Study locations
NCT03224351 is a Phase 2 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 124 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT03224351, a Phase 2 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 124 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation of the CF transmembrane conductance regulator (CFTR) gene (F/F genotype), or who are heterozygous for the F508del mutation and a minimal function (MF) CFTR mutation not likely to respond to TEZ, IVA, or TEZ/IVA (F/MF genotypes).
Conditions Studied
Interventions
- DRUG IVA
- DRUG VX-659
- DRUG TEZ/IVA
- DRUG Placebo (matched to VX-659/TEZ/IVA)
- DRUG TEZ
Study Locations (20)
New York
- Albany Medical College - Albany
- Northwell Health, Long Island Jewish Medical Center - New Hyde Park
- Columbia University Medical Center - New York
- SUNY Upstate Medical University - Syracuse
Massachusetts
- Boston Children's Hospital - Boston
- University of Massachusetts Memorial Medical Center - Worcester
Michigan
- University of Michigan Health System - Ann Arbor
- Helen DeVos Children's Hospital CF Center - Grand Rapids
Connecticut
- Yale New Haven Hospital - New Haven
Florida
- University of Miami/Miller School of Medicine - Miami
Illinois
- Advocate Children's Hospital - Park Ridge / North Suburban Pulmonary and Critical Care Consultants - Morton Grove
Indiana
- Indiana University Health - Indianapolis
Iowa
- The University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 124 participants |
| Start Date | 2017-08-08 |
| Est. Completion | 2018-02-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03224351
The ClinicalTrials.gov registry entry for NCT03224351 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 124 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 (31% lower). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 5 interventions - of which IVA is the first listed.
NCT03224351 reports 20 study locations spanning 15 distinct geographic areas - top geographies include New York, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT03224351 about?
NCT03224351 is a clinical study titled "A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis". This is a Phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (TEZ/IVA)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of VX-659 in triple combination (TC) with TEZ and IVA in subjects with cystic fibrosis (CF) who are homozygous f...
What is the current status of trial NCT03224351?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 124 participants. The study started on 2017-08-08. Estimated completion is 2018-02-28.
What conditions does trial NCT03224351 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT03224351?
The interventions under investigation include: IVA (DRUG), VX-659 (DRUG), TEZ/IVA (DRUG), Placebo (matched to VX-659/TEZ/IVA) (DRUG), TEZ (DRUG).
Who is sponsoring clinical trial NCT03224351?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03224351 being conducted?
This trial has 20 study locations across Connecticut, Florida, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.