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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
  Purpose

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 Intervention Phase
HHT
Morbus Osler
Epistaxis
 Drug: Bevacizumab
Drug: NaCl
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Double Blind Placebo Controlled Trial of Intranasal Submucosal Bevacizumab in Hereditary Hemorrhagic Telangiectasia

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 15
Study Start Date: March 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314274

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

Locations
Austria
Universitätsklinik für HNO, Medizinische Univeristät Wien Recruiting
Vienna, Austria, 1090
Contact: Dominik Riss, MD         dominik.riss@meduniwien.ac.at    
Principal Investigator: Christoph Arnoldner, MD            
Sub-Investigator: Dominik Riss, MD            
Sponsors and Collaborators
Medical University of Vienna
  More Information

No publications provided

Responsible Party: Martin Burian, Prof. Dr. Martin Burian, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01314274     History of Changes
Other Study ID Numbers: bevacizumab HHT, 2009-018049-19
Study First Received: March 9, 2011
Last Updated: December 13, 2011
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
Epistaxis
Osler
Weber
 Rendu
HHT
Hereditary haemorrhagic telangiectasia

Additional relevant MeSH terms:
Epistaxis
Telangiectasia, Hereditary Hemorrhagic
Telangiectasis
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Hematologic Diseases
 Vascular Malformations
Cardiovascular Abnormalities
Congenital Abnormalities
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013