Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)

Medical University of Vienna15 enrolled

Overview

In a case series intranasal submucosal bevacizumab has been shown to reduce epistaxis in patients suffering from Hereditary Haemorrhagic Telangiectasia together with KTP Laser therapy. The aim of this study is to evaluate the effectiveness of submucosal intranasal bevacizumab compared to placebo in a randomized double blind trial setting.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

HHT Morbus Osler Epistaxis

Interventions

BevacizumabDRUG

100mg intranasal submucosal bevacizumab in 10ml

NaClDRUG

10ml of 0.9% NaCl intranasal submucosal

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosed and staged HHT (Shovlin et al 2000) * Age 18-80 * Minimum of 2 episodes of epistaxis/ week * Ability and willingness to complete diary and comply with study requirements. 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 (\<3 months) or planned surgery * Proteinuria * Nasal intervention (Laser or Cautery) in pretreatment phase * Allergy to local anesthetic

Locations (1)

Universitätsklinik für HNO, Medizinische Univeristät Wien

Vienna, Austria

Outcomes

Primary Outcomes

relative change in average daily Epistaxis VAS scores compared to baseline

Daily epistaxis VAS scores are recorded in a diary. The baseline score is the average daily epistaxis VAS score 4 weeks before treatment (day -28 to 0). This score is compared to the average daily VAS score day 10-84 posttreatment. The relative change of this average score compared to baseline is the primary outcome.

Time frame: day 10 - 84 posttreatment

Secondary Outcomes

Epistaxis Severity Score HHT-ESS compared to baseline

Time frame: 3 months post treatment

Epistaxis frequency, duration and severity compared to baseline

Time frame: day 10 - 84 posttreatment

Number of emergency department visits due to epistaxis compared to baseline

Time frame: day 10 - 84 posttreatment

lab results (ferritin values, Hb, Hct) compared to baseline

Time frame: day 84 posttreatment

Number of transfusions needed compared to baseline

Time frame: day 10-84 posttreatment

Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity

Time frame: day 10-84 posttreatment

Data from ClinicalTrials.gov

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