Cystic FibrosisNCT01863238
An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Vertex Pharmaceuticals Incorporated at 38 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Ophthalmologic examinations and Ivacaftor Exposed
- How many people
- 95 participants
- Where
- 38 sitesUnited States
- Study dates
- May 2013to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
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)
Who may be able to join
- 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.
- Subject must reside in the US and be receiving or planning to receive commercially-available ivacaftor.
Who cannot join
- Subject is enrolled in an ivacaftor clinical study in which ivacaftor exposure is mandated by the protocol.
- Subject has received surgery for cataracts
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
United States38 sites
Study site
Akron, Ohio
Study site
Ann Arbor, Michigan
Study site
Aurora, Colorado
Study site
Birmingham, Alabama
Study site
Boise, Idaho
Study site
Boston, Massachusetts
Study site
Charleston, South Carolina
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Columbia, Missouri
Study site
Detroit, Michigan
Study site
Fort Worth, Texas
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Kansas City, Kansas
Study site
Kansas City, Missouri
Study site
Knoxville, Tennessee
Study site
Long Beach, California
Study site
Louisville, Kentucky
Study site
Minneapolis, Minnesota
Study site
Morgantown, West Virginia
Study site
Nashville, Tennessee
Study site
Oklahoma City, Oklahoma
Study site
Omaha, Nebraska
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Maine
Study site
Portland, Oregon
Study site
Providence, Rhode Island
Study site
Rochester, New York
Study site
Salt Lake City, Utah
Study site
Seattle, Washington
Study site
Spokane, Washington
Study site
St. Petersburg, Florida
Study site
Toledo, Ohio
Study site
Tucson, Arizona
Study site
Wilmington, Delaware
About this study
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
- Cystic Fibrosis
- Being tested
- Ophthalmologic examinations, Ivacaftor Exposed
- Keywords
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ophthalmologic examinationsOther
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.
Ivacaftor ExposedDrug
| Study group | Role | What they receive |
|---|---|---|
| Ivacaftor Treated | Not described Receives: Other: Ophthalmologic examinations; Drug: Ivacaftor Exposed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cataracts (lens opacities)
Measured: Through Month 24
Best corrected distance vision
Measured: Through Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startMay 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cystic Fibrosis Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863238
- Sponsor's protocol ID
- VX12-770-115
- Status last verified
- Jul 2015
- First submitted
- 22 May 2013
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT01863238
- Acronym / sponsor ID
- VX12-770-115
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Cystic Fibrosis Foundation
- Study start
- May 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 27 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivacaftor Treated | – | Other: Ophthalmologic examinations, Drug: Ivacaftor Exposed |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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)
Key inclusion criteria (2 listed)
- 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.
- Subject must reside in the US and be receiving or planning to receive commercially-available ivacaftor.
Key exclusion criteria (2 listed)
- Subject is enrolled in an ivacaftor clinical study in which ivacaftor exposure is mandated by the protocol.
- Subject has received surgery for cataracts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ophthalmologic examinationsSubjects 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. | Other | Ivacaftor Treated |
| Ivacaftor Exposed | Drug | Ivacaftor Treated |
Primary outcome
Cataracts (lens opacities)
Time frame: Through Month 24
Best corrected distance vision
Time frame: Through Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Vertex Pharmaceuticals Incorporated at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cataracts (lens opacities) (time frame: Through Month 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.