Epistaxis Clinical Trial
Official title:
Efficacy of a Bevacizumab Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
Hereditary Hemorrhagic Telangiectasia (HHT) is a rare (~ 1/6000) but ubiquitous genetic
disease. It is associated with abnormal angiogenesis and autosomal dominant inheritance,
leading to telangiectasias and arteriovenous fistulae. More than 95% of patients are
concerned by epistaxis (nosebleeds). These events are spontaneous, repeated, irregular, both
diurnal and nocturnal, a source of anemia, disabling and very socially embarrassing.
Anti-angiogenic treatments, including bevacizumab, are a new therapeutic option in HHT.
The aim of this study is to evaluate 3 months after the end of the treatment the efficacy on
the duration of the nosebleeds with 3 different doses (25, 50 and 75 mg) of bevacizumab
administered as a nasal spray in a repeated manner (3 administrations) in patients with
Hereditary Hemorrhagic Telangiectasia complicated by nosebleeds.
This randomized, double-blind, placebo-controlled, seamless phase II/III study is to be
carried out on 4 groups of 20 patients for first step and 2 groups of 20 to 40 patients for
second step
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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