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

August 8, 2013 updated by: Martin Burian, Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1090
        • Universitätsklinik für HNO, Medizinische Univeristät Wien

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bevacizumab
submucosal intranasal bevacizumab on day 0
Drug: Bevacizumab
100mg intranasal submucosal bevacizumab in 10ml
Placebo Comparator: placebo
0.9% NaCl intranasal submucosal on day 0
Drug: NaCl
10ml of 0.9% NaCl intranasal submucosal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
relative change in average daily Epistaxis VAS scores compared to baseline
Time Frame: 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.
day 10 - 84 posttreatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 11, 2011

First Posted (Estimate)

March 14, 2011

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • bevacizumab HHT
  • 2009-018049-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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