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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01314274

Enrollment

Registered

2011-03-14

Start date

2011-03-31

Completion date

2013-06-30

Last updated

2013-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epistaxis, HHT, Morbus Osler

Keywords

Epistaxis, Osler, Weber, Rendu, HHT, Hereditary haemorrhagic telangiectasia

Brief summary

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.

Interventions

DRUGBevacizumab

100mg intranasal submucosal bevacizumab in 10ml

DRUGNaCl

10ml of 0.9% NaCl intranasal submucosal

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
relative change in average daily Epistaxis VAS scores compared to baseline	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

Measure	Time frame
Epistaxis frequency, duration and severity compared to baseline	day 10 - 84 posttreatment
Number of emergency department visits due to epistaxis compared to baseline	day 10 - 84 posttreatment
Epistaxis Severity Score HHT-ESS compared to baseline	3 months post treatment
Number of transfusions needed compared to baseline	day 10-84 posttreatment
Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity	day 10-84 posttreatment
lab results (ferritin values, Hb, Hct) compared to baseline	day 84 posttreatment

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026