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

• Register: EUCTR
• Last refreshed on: 12 May 2014
• Main ID: EUCTR2009-018049-19-AT
• Date of registration: 23/11/2010
• Prospective Registration: Yes
• Primary sponsor: Medizinische Universität Wien,Univ.Klinik f.Hals-, Nasen- und Ohrenkrankheiten
• Public title: A randomized double blind placebo controlled trial of intranasal submucosal bevacizumab in hereditary hemorrhagic telangiectasia - Bevazizumab in HHT
• Scientific title: A randomized double blind placebo controlled trial of intranasal submucosal bevacizumab in hereditary hemorrhagic telangiectasia - Bevazizumab in HHT
• Date of first enrolment: 13/12/2010
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-018049-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Austria

Key inclusion & exclusion criteria

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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

epistaxis

Intervention(s)

Trade Name: AVASTIN 25 mg/ml - Konzentrat zur Herstellung einer Infusionsloesung
Pharmaceutical Form: Solution for injection
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: -10

Trade Name: PHYSIOLOGISCHE Kochsalzloesung "Fresenius" - Infusionsloesung
Product Name: PHYSIOLOGISCHE Kochsalzloesung "Fresenius" - Infusionsloesung
Pharmaceutical Form: Solution for injection
CAS Number: 7647-14-5
Other descriptive name: SODIUM CHLORIDE
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Solution for infusion
Route of administration of the placebo: Intranasal use (Noncurrent)

Primary Outcome(s)

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

Primary end point(s): • Relative difference in average of daily Epistaxis VAS scores 28 days pretreatment to days 10- 84 post treatment

Secondary Objective: • To assess effects on duration, severity and frequency of epistaxis,
• To asses effects on frequency of Emergency department visits including emergency epistaxis measures
• To assess differences in treatment in patients with different severity of the disease,
• To assess differences in treatment in patients of different age groups,
• To assess the effect on laboratory parameters (ferritin, Hb, Hkt)
• To assess the effect on frequency of transfusions