An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis

August 22, 2016 updated by: Vertex Pharmaceuticals Incorporated
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Long Beach, California, United States
    • Colorado
      • Aurora, Colorado, United States
    • Delaware
      • Wilmington, Delaware, United States
    • Florida
      • St. Petersburg, Florida, United States
    • Idaho
      • Boise, Idaho, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kansas
      • Kansas City, Kansas, United States
    • Kentucky
      • Louisville, Kentucky, United States
    • Maine
      • Portland, Maine, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
    • Minnesota
      • Minneapolis, Minnesota, United States
    • Missouri
      • Columbia, Missouri, United States
      • Kansas City, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Rochester, New York, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
      • Pittsburgh, Pennsylvania, United States
    • Rhode Island
      • Providence, Rhode Island, United States
    • South Carolina
      • Charleston, South Carolina, United States
    • Tennessee
      • Knoxville, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Fort Worth, Texas, United States
      • Houston, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
    • Virginia
      • Charlottesville, Virginia, United States
    • Washington
      • Seattle, Washington, United States
      • Spokane, Washington, United States
    • West Virginia
      • Morgantown, West Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 11 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric patients with CF who are 11 years of age or younger at the time of initiation of treatment with ivacaftor and are receiving or planning to receive commercially-available ivacaftor in the United States (US)

Description

Inclusion Criteria:

  1. Subject must be 11 years of age or younger at the time of treatment initiation with ivacaftor (as part of clinical trial) or commercially-available ivacaftor.
  2. Subject must reside in the US and be receiving or planning to receive commercially-available ivacaftor.

Exclusion Criteria:

  1. Subject is enrolled in an ivacaftor clinical study in which ivacaftor exposure is mandated by the protocol.
  2. Subject has received surgery for cataracts

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ivacaftor Treated
Other: Ophthalmologic examinations
Subjects will undergo an ophthalmologic examination at study entry (Day 1) and every 6 months thereafter for 2 years (Months 6, 12, 18, and 24). Subjects who discontinue treatment with commercially-available ivacaftor for any reason and are willing to continue participation in the study will complete the study.
Drug: Ivacaftor Exposed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cataracts (lens opacities)
Time Frame: Through Month 24
Through Month 24
Best corrected distance vision
Time Frame: Through Month 24
Through Month 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vertex Pharmaceuticals Incorporated

Collaborators

Cystic Fibrosis Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 22, 2013

First Submitted That Met QC Criteria

May 22, 2013

First Posted (Estimate)

May 27, 2013

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VX12-770-115

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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