Efficacy of a Bevacizumab Nasal Spray as a Treatment for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

Sponsor
Hospices Civils de Lyon
Study ID
NCT02106520
Phase
PHASE2/PHASE3
Status
Terminated

Conditions

  • Epistaxis
  • Hereditary Hemorrhagic Telangiectasia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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

Key Dates

First listed
Apr 8, 2014
Start date
Apr 30, 2014
Status verified
Nov 2015
Primary completion
Jun 30, 2015
Completion
Sep 30, 2015

Study Design

Enrollment
80 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bevacizumab 25mg
    Three administrations of 25 mg of Bevacizumab spaced of 14 days
  • Experimental: Bevacizumab 50mg
    Three administrations of 50 mg of Bevacizumab spaced of 14 days
  • Experimental: Bevacizumab 75mg
    Three administrations of 75 mg of Bevacizumab spaced of 14 days
  • Placebo Comparator: Placebo
    Three administrations of placebo spaced of 14 days

Primary Outcome Measure

mean duration of epistaxis [ Time Frame: 3 months after treatment ]

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