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

Epistaxis Clinical Trial

Official title:

A Randomized Double Blind Placebo Controlled Trial of Intranasal Submucosal Bevacizumab in Hereditary Hemorrhagic Telangiectasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314274
• Other study ID #: bevacizumab HHT
• Secondary ID: 2009-018049-19
• Status: Completed
• Phase: Phase 2
• First received: March 9, 2011
• Last updated: August 8, 2013
• Start date: March 2011
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epistaxis
• HHT
• Morbus Osler
• Telangiectasia, Hereditary Hemorrhagic
• Telangiectasis

Intervention

Drug:
• Bevacizumab
100mg intranasal submucosal bevacizumab in 10ml
• NaCl
10ml of 0.9% NaCl intranasal submucosal

Locations

Country	Name	City	State
Austria	Universitätsklinik für HNO, Medizinische Univeristät Wien	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	day 10 - 84 posttreatment	No
Secondary	Epistaxis Severity Score HHT-ESS compared to baseline		3 months post treatment	No
Secondary	Epistaxis frequency, duration and severity compared to baseline		day 10 - 84 posttreatment	No
Secondary	Number of emergency department visits due to epistaxis compared to baseline		day 10 - 84 posttreatment	No
Secondary	lab results (ferritin values, Hb, Hct) compared to baseline		day 84 posttreatment	No
Secondary	Number of transfusions needed compared to baseline		day 10-84 posttreatment	No
Secondary	Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity		day 10-84 posttreatment	No