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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 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.

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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

Cystic Fibrosis

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

FieldValue
Enrollment Target 95 participants
Start Date 2013-05
Est. Completion 2016-05

Sponsor

Vertex Pharmaceuticals Incorporated

191 total trials

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What the Registry Record Tells You About NCT01863238

The ClinicalTrials.gov registry entry for NCT01863238 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 95 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 (47% 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 2 interventions - of which Ophthalmologic examinations is the first listed.

NCT01863238 reports 20 study locations spanning 18 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.