We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01314274
Recruitment Status : Completed
First Posted : March 14, 2011
Last Update Posted : August 12, 2013
Information provided by (Responsible Party):
Martin Burian, Medical University of Vienna

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.

Condition or disease Intervention/treatment Phase
HHT Morbus Osler Epistaxis Drug: Bevacizumab Drug: NaCl Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Placebo Controlled Trial of Intranasal Submucosal Bevacizumab in Hereditary Hemorrhagic Telangiectasia
Study Start Date : March 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

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

Primary Outcome Measures :
  1. 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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01314274

Layout table for location information
Universitätsklinik für HNO, Medizinische Univeristät Wien
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Martin Burian, Prof. Dr. Martin Burian, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01314274    
Other Study ID Numbers: bevacizumab HHT
2009-018049-19 ( EudraCT Number )
First Posted: March 14, 2011    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013
Keywords provided by Martin Burian, Medical University of Vienna:
Hereditary haemorrhagic telangiectasia
Additional relevant MeSH terms:
Layout table for MeSH terms
Telangiectasia, Hereditary Hemorrhagic
Vascular Diseases
Cardiovascular Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Hemostatic Disorders
Hemorrhagic Disorders
Hematologic Diseases
Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors