A randomized double blind placebo controlled trial of intranasal submucosal bevacizumab in hereditary hemorrhagic telangiectasia - Bevazizumab in HHT

Conditions: epistaxis

Registration Number: EUCTR2009-018049-19-AT

Lead Sponsor: Medizinische Universität Wien,Univ.Klinik f.Hals-, Nasen- und Ohrenkrankheiten

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 30

Inclusion Criteria

Diagnosed HHT (Shovlin et al 2000)
Age 18-80
Minimum of 2 episodes of epistaxis/ week
Ability and willigness to complete diary and comply with study requirements

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Uncontrolled hypertension (systolic blood pressure > 150mmHg, diastolic blood pressure > 90mmHg)
History of a thromboembolic event, including myocardial infarction or cerebral vascular accident
Malignancy of the upper respiratory tract within the last year
Recent (<3months) or planned surgery
Nasal intervention (Laser or Cautery) in pretreatment phase
Allergy to local anaesthetic

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate treatment efficacy of intranasal submucosal bevacizumab in comparison to placebo, as measured by relative reduction in average VAS scores of epistaxis ;Secondary Objective: •To assess effects on duration, severity and frequency of epistaxis,<br>•To asses effects on frequency of Emergency department visits including emergency epistaxis measures<br>•To assess differences in treatment in patients with different severity of the disease,<br>•To assess differences in treatment in patients of different age groups,<br>•To assess the effect on laboratory parameters (ferritin, Hb, Hkt)<br>•To assess the effect on frequency of transfusions<br>;Primary end point(s): •Relative difference in average of daily Epistaxis VAS scores 28 days pretreatment to days 10- 84 post treatment

Secondary Outcome Measures