Status:
UNKNOWN
Study of the Benefit of Early Treatment With an Endothelin Inhibitor (Bosentan) in Patients With Sudden Blindness Due to Giant Cell Arteritis: CECIBO
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Arteritis, Giant Cell
Blindness and Low Vision
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
Giant cell arteritis , also named Horton's disease, is the most common vasculitis in subjects over 50 years old. The incidence increases with age : from 188 to 290 cases per million inhabitants per ye...
Eligibility Criteria
Inclusion
- Decreased visual acuity (BVA) \<5 days, regardless of degree of severity, abrupt onset in the context of newly diagnosed or suspected Horton's disease at this loss of visual acuity
- Able to sign the consent
- Affiliated to the social security system
- Already under conventional treatment of Horton's disease or the: requiring: Corticosteroids and + - anti-platelet aggregators and / or LMWH at the discretion of the referring physician for its vasculitis and + - immunosuppressive or biotherapy if necessary.
Exclusion
- Underlying hepatocellular insufficiency known
- Patient under guardianship or curator
- Hypersensitivity to the active substance or to any of the excipients
- Moderate to severe hepatic insufficiency corresponding to class B or C of the Child-Pugh classification
- Any other ophthalmological pathology explaining the sudden drop in vision: retinal detachment, retinal hemorrhage, posterior uveitis, nonarteritic arterial occlusion, cortical stroke
- Serum levels of hepatic aminotransferases, aspartate aminotransferases (ASTs) and / or alanine aminotransferases (ALATs), greater than 3 times the upper limit of normal before start of treatment
- Patient under treatment with cyclosporine A, antiretrovirals, glibenclamide or Rifampicin.
- Pregnant or lactating women
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT03841734
Start Date
March 1 2019
End Date
March 1 2021
Last Update
February 15 2019
Active Locations (1)
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1
CH de Cannes
Cannes, France