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

Sponsor
Medical University of Vienna
Study ID
NCT01314274
Phase
PHASE2
Status
Completed

Conditions

  • Epistaxis
  • HHT
  • Morbus Osler

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    100mg intranasal submucosal bevacizumab in 10ml
  • NaCl — DRUG
    10ml of 0.9% NaCl intranasal submucosal

Study Details

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.

Key Dates

First listed
Mar 14, 2011
Start date
Mar 31, 2011
Status verified
Aug 2013
Primary completion
Jun 30, 2013
Completion
Jun 30, 2013

Study Design

Enrollment
15 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: bevacizumab
    submucosal intranasal bevacizumab on day 0
  • Placebo Comparator: placebo
    0.9% NaCl intranasal submucosal on day 0

Primary Outcome Measure

relative change in average daily Epistaxis VAS scores compared to baseline [ Time Frame: day 10 - 84 posttreatment ]

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