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

Phase 2

Completed

• Conditions: HHT; Morbus Osler; Epistaxis
• Interventions: Drug: NaCl; Drug: Bevacizumab

• Registration Number: NCT01314274
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-09
• Study First Submitted QC: 2011-03-11
• Study First Posted: 2011-03-14
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	NaCl	0.9% NaCl intranasal submucosal on day 0
bevacizumab	Bevacizumab	submucosal intranasal bevacizumab on day 0

Primary Outcome Measures

Name	Time	Method
relative change in average daily Epistaxis VAS scores compared to baseline	day 10 - 84 posttreatment	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.

Secondary Outcome Measures

Name	Time	Method
Epistaxis Severity Score HHT-ESS compared to baseline	3 months post treatment
Epistaxis frequency, duration and severity compared to baseline	day 10 - 84 posttreatment
Number of emergency department visits due to epistaxis compared to baseline	day 10 - 84 posttreatment
lab results (ferritin values, Hb, Hct) compared to baseline	day 84 posttreatment
Number of transfusions needed compared to baseline	day 10-84 posttreatment
Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity	day 10-84 posttreatment

Trial Locations

Locations (1)

Universitätsklinik für HNO, Medizinische Univeristät Wien; 🇦🇹 Vienna, Austria