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NCT02725567 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation
A Phase 3 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 3
- Development phase
- 57
- Enrollment target
- 20
- Study locations
NCT02725567 is a Phase 3 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 57 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (68% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT02725567, a Phase 3 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 57 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an ivacaftor-responsive CF transmembrane conductance regulator (CFTR) gene mutation.
Conditions Studied
Interventions
- DRUG IVA
Study Locations (20)
Other
- - South Brisbane
- - Westmead
- - Toronto
- - Dublin
- - Edinburgh
- - Leicester
Alabama
- - Birmingham
California
- - Palo Alto
Georgia
- - Atlanta
Illinois
- - Chicago
Indiana
- - Indianapolis
Maryland
- - Baltimore
Massachusetts
- - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2016-06-02 |
| Est. Completion | 2022-06-28 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02725567
The ClinicalTrials.gov registry entry for NCT02725567 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 57 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 (68% 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 1 intervention - of which IVA is the first listed.
NCT02725567 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, Alabama, California.
Frequently Asked Questions
What is clinical trial NCT02725567 about?
NCT02725567 is a clinical study titled "A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation". The purpose of this study was to evaluate the safety of ivacaftor treatment, and PK of ivacaftor and metabolites in participants with cystic fibrosis (CF) who are \<24 months of age at treatment initiation and have an ivacaftor-responsive CF transmembrane conductance regulator (CFTR) gene mutation.
What is the current status of trial NCT02725567?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 57 participants. The study started on 2016-06-02. Estimated completion is 2022-06-28.
What conditions does trial NCT02725567 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT02725567?
The interventions under investigation include: IVA (DRUG).
Who is sponsoring clinical trial NCT02725567?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02725567 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Illinois, Indiana. 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.