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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01314274
First Posted: March 14, 2011
Last Update Posted: August 12, 2013
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.
Information provided by (Responsible Party):
Martin Burian, Medical University of Vienna
March 9, 2011
March 14, 2011
August 12, 2013
March 2011
June 2013   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01314274 on ClinicalTrials.gov Archive Site
  • Epistaxis Severity Score HHT-ESS compared to baseline [ Time Frame: 3 months post treatment ]
  • Epistaxis frequency, duration and severity compared to baseline [ Time Frame: day 10 - 84 posttreatment ]
  • Number of emergency department visits due to epistaxis compared to baseline [ Time Frame: day 10 - 84 posttreatment ]
  • lab results (ferritin values, Hb, Hct) compared to baseline [ Time Frame: day 84 posttreatment ]
  • Number of transfusions needed compared to baseline [ Time Frame: 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 ]
Same as current
Not Provided
Not Provided
 
Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • HHT
  • Morbus Osler
  • Epistaxis
  • Drug: Bevacizumab
    100mg intranasal submucosal bevacizumab in 10ml
  • Drug: NaCl
    10ml of 0.9% NaCl intranasal submucosal
  • 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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
 
NCT01314274
bevacizumab HHT
2009-018049-19 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Martin Burian, Medical University of Vienna
Medical University of Vienna
Not Provided
Not Provided
Medical University of Vienna
August 2013

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