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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martin Burian, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01314274
First received: March 9, 2011
Last updated: August 8, 2013
Last verified: August 2013

March 9, 2011
August 8, 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 ] [ 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.
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 ] [ 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 ]
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01314274
bevacizumab HHT, 2009-018049-19
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