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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02375685 |
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Date of registration:
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16/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Long-term Safety of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis (EYEGUARD-X)
EYEGUARD-X |
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Scientific title:
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A Safety Open-label Study of Gevokizumab in the Treatment of Patients With Chronic Non-infectious Uveitis Disease, an eXtension Study. The EYEGUARD-X Study |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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71 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02375685 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 3
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Countries of recruitment
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Australia
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Austria
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France
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Germany
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Greece
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Italy
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Korea, Republic of
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Portugal
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Spain
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Taiwan
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Tunisia
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Turkey
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United Kingdom
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- either completed participation to one of the following: CL3-78989-002 open-label
extension, or X052130/CL3-78989-005 double-masked period or open-label period, or
X052131/CL3-78989-006 double-masked period or open-label period, or currently
benefiting from gevokizumab compassionate use after participation in gevokizumab
uveitis studies
- Male or female, age =18 (or legal age of majority in the country) at selection.
- For subject with reproductive potential, a willingness to use highly effective
contraceptive measures
Exclusion Criteria:
- Meeting criteria for discontinuation of any of gevokizumab uveitis previous study.
- Infectious uveitis and masquerade syndrome
- History of severe allergic or anaphylactic reaction to study drug administration
during previous study or to gevokizumab or any of its excipient.
- Currently active infectious disease.
Other protocol-defined inclusion/exclusion criteria may apply
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Chronic Uveitis
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Intervention(s)
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Biological: Gevokizumab
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Primary Outcome(s)
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Safety endpoints (adverse events, ...)
[Time Frame: 108 weeks]
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Secondary ID(s)
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2013-004973-29
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CL3-78989-019
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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