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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Vienna
• Treatments: Bevacizumab

Criteria

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