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

Primary Purpose

HHT, Morbus Osler, Epistaxis

Status
Completed
Phase
Phase 2
Locations
Austria
Study Type
Interventional
Intervention
Bevacizumab
NaCl
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HHT focused on measuring Epistaxis, Osler, Weber, Rendu, HHT, Hereditary haemorrhagic telangiectasia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Universitätsklinik für HNO, Medizinische Univeristät Wien

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

bevacizumab

placebo

Arm Description

submucosal intranasal bevacizumab on day 0

0.9% NaCl intranasal submucosal on day 0

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Epistaxis Severity Score HHT-ESS compared to baseline
Epistaxis frequency, duration and severity compared to baseline
Number of emergency department visits due to epistaxis compared to baseline
lab results (ferritin values, Hb, Hct) compared to baseline
Number of transfusions needed compared to baseline
Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity

Full Information

First Posted
March 9, 2011
Last Updated
August 8, 2013
Sponsor
Medical University of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01314274
Brief Title
Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
Official Title
A Randomized Double Blind Placebo Controlled Trial of Intranasal Submucosal Bevacizumab in Hereditary Hemorrhagic Telangiectasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HHT, Morbus Osler, Epistaxis
Keywords
Epistaxis, Osler, Weber, Rendu, HHT, Hereditary haemorrhagic telangiectasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
bevacizumab
Arm Type
Experimental
Arm Description
submucosal intranasal bevacizumab on day 0
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
0.9% NaCl intranasal submucosal on day 0
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
100mg intranasal submucosal bevacizumab in 10ml
Intervention Type
Drug
Intervention Name(s)
NaCl
Intervention Description
10ml of 0.9% NaCl intranasal submucosal
Primary Outcome Measure Information:
Title
relative change in average daily Epistaxis VAS scores compared to baseline
Description
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.
Time Frame
day 10 - 84 posttreatment
Secondary Outcome Measure Information:
Title
Epistaxis Severity Score HHT-ESS compared to baseline
Time Frame
3 months post treatment
Title
Epistaxis frequency, duration and severity compared to baseline
Time Frame
day 10 - 84 posttreatment
Title
Number of emergency department visits due to epistaxis compared to baseline
Time Frame
day 10 - 84 posttreatment
Title
lab results (ferritin values, Hb, Hct) compared to baseline
Time Frame
day 84 posttreatment
Title
Number of transfusions needed compared to baseline
Time Frame
day 10-84 posttreatment
Title
Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity
Time Frame
day 10-84 posttreatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Universitätsklinik für HNO, Medizinische Univeristät Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

Citations:
PubMed Identifier
24595923
Citation
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.
Results Reference
derived

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

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