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

Medical University of Vienna

Status and phase: Completed; Phase 2

Conditions: HHT; Morbus Osler; Epistaxis

Treatments: Drug: NaCl; Drug: Bevacizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01314274

bevacizumab HHT

2009-018049-19 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

bevacizumab

Experimental group

Description:

submucosal intranasal bevacizumab on day 0

Treatment:

Drug: Bevacizumab

placebo

Placebo Comparator group

Description:

0.9% NaCl intranasal submucosal on day 0

Treatment:

Drug: NaCl