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

This study is currently recruiting participants.

Verified December 2011 by Medical University of Vienna

Sponsor:

Information provided by (Responsible Party):

Martin Burian, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT01314274

First received: March 9, 2011

Last updated: December 13, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 9, 2011

Last Updated Date

December 13, 2011

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

relative change in average daily Epistaxis VAS scores compared to baseline [ Time Frame: day 10 - 84 posttreatment ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01314274 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Epistaxis Severity Score HHT-ESS compared to baseline [ Time Frame: 3 months post treatment ] [ Designated as safety issue: No ]
Epistaxis frequency, duration and severity compared to baseline [ Time Frame: day 10 - 84 posttreatment ] [ Designated as safety issue: No ]
Number of emergency department visits due to epistaxis compared to baseline [ Time Frame: day 10 - 84 posttreatment ] [ Designated as safety issue: No ]
lab results (ferritin values, Hb, Hct) compared to baseline [ Time Frame: day 84 posttreatment ] [ Designated as safety issue: No ]
Number of transfusions needed compared to baseline [ Time Frame: day 10-84 posttreatment ] [ Designated as safety issue: No ]
Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity [ Time Frame: day 10-84 posttreatment ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

HHT
Morbus Osler
Epistaxis

Intervention ^ICMJE

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

Study Arm (s)

Experimental: bevacizumab
submucosal intranasal bevacizumab on day 0

Intervention: Drug: Bevacizumab
Placebo Comparator: placebo
0.9% NaCl intranasal submucosal on day 0

Intervention: Drug: NaCl

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dominik Riss, MD	+43 1 40400 3376	dominik.riss@meduniwien.ac.at
Contact: Christoph Arnoldner, MD

Location Countries ^ICMJE

Austria

Administrative Information

NCT Number ^ICMJE

NCT01314274

Other Study ID Numbers ^ICMJE

bevacizumab HHT, 2009-018049-19

Has Data Monitoring Committee

Not Provided

Responsible Party

Martin Burian, Medical University of Vienna

Study Sponsor ^ICMJE

Medical University of Vienna

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Not Provided

Information Provided By

Medical University of Vienna

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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