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NCT01863238 · ClinicalTrials.gov registry record
An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
A clinical trial of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- 95
- Enrollment target
- 20
- Study locations
NCT01863238: Completed study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
NCT01863238 is a study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 95 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (47% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01863238, a study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- 95 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to evaluate the risk of cataracts (lens opacities) and describe the best corrected distance vision (with glasses/contacts for those who wear them) of pediatric patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor treatment initiation and are receiving or planning to receive commercially-available ivacaftor in the US.
Conditions Studied
Interventions
- OTHER Ophthalmologic examinations
- DRUG Ivacaftor Exposed
Study Locations (20)
Michigan
- - Ann Arbor
- - Detroit
Missouri
- - Columbia
- - Kansas City
Alabama
- - Birmingham
Arizona
- - Tucson
California
- - Long Beach
Colorado
- - Aurora
Delaware
- - Wilmington
Florida
- - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2013-05 |
| Est. Completion | 2016-05 |
What the finished NCT01863238 record still lists
NCT01863238 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 95 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 2 interventions - of which Ophthalmologic examinations is the first listed.
NCT01863238 names 20 study sites across 18 states, led by Michigan, Missouri, Alabama.
Frequently Asked Questions
What is clinical trial NCT01863238 about?
NCT01863238 is a clinical study titled "An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis". This study is designed to evaluate the risk of cataracts (lens opacities) and describe the best corrected distance vision (with glasses/contacts for those who wear them) of pediatric patients with Cystic Fibrosis who are 11 years of age or younger at the time of ivacaftor treatment initiation and ar...
What is the current status of trial NCT01863238?
This trial is currently completed. The enrollment target is 95 participants. The study started on 2013-05. Estimated completion is 2016-05.
What conditions does trial NCT01863238 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT01863238?
The interventions under investigation include: Ophthalmologic examinations (OTHER), Ivacaftor Exposed (DRUG).
Who is sponsoring clinical trial NCT01863238?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01863238 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01863238's enrollment target sits among peer trials
95 64th of 169 higher than 106 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.
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