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NCT Number: NCT01314274

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

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.

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Key information

Conditions

HHT Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Epistaxis Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Morbus Osler Nose Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Telangiectasia, Hereditary Hemorrhagic Telangiectasis Vascular Diseases Vascular Malformations

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinik für HNO, Medizinische Univeristät Wien

Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bevacizumab

Drug

100mg intranasal submucosal bevacizumab in 10ml

NaCl

Drug

10ml of 0.9% NaCl intranasal submucosal

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

A Randomized Double Blind Placebo Controlled Trial of Intranasal Submucosal Bevacizumab in Hereditary Hemorrhagic Telangiectasia

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 14, 2011
Registry last updated
Aug 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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