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

NCT ID: NCT01314274

Last Updated: 2013-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2013-06-30

Brief Summary

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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

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Conditions

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HHT Morbus Osler Epistaxis

Keywords

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Epistaxis Osler Weber Rendu HHT Hereditary haemorrhagic telangiectasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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bevacizumab

submucosal intranasal bevacizumab on day 0

Group Type EXPERIMENTAL

Bevacizumab

Intervention Type DRUG

100mg intranasal submucosal bevacizumab in 10ml

placebo

0.9% NaCl intranasal submucosal on day 0

Group Type PLACEBO_COMPARATOR

NaCl

Intervention Type DRUG

10ml of 0.9% NaCl intranasal submucosal

Interventions

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Bevacizumab

100mg intranasal submucosal bevacizumab in 10ml

Intervention Type DRUG

NaCl

10ml of 0.9% NaCl intranasal submucosal

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Martin Burian

Prof. Dr. Martin Burian

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universitätsklinik für HNO, Medizinische Univeristät Wien

Vienna, , Austria

Site Status

Countries

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Austria

References

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Riss D, Burian M, Wolf A, Kranebitter V, Kaider A, Arnoldner C. Intranasal submucosal bevacizumab for epistaxis in hereditary hemorrhagic telangiectasia: a double-blind, randomized, placebo-controlled trial. Head Neck. 2015 Jun;37(6):783-7. doi: 10.1002/hed.23655. Epub 2014 Apr 30.

Reference Type DERIVED
PMID: 24595923 (View on PubMed)

Other Identifiers

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2009-018049-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

bevacizumab HHT

Identifier Type: -

Identifier Source: org_study_id