A randomized double blind placebo controlled trial of intranasal submucosal bevacizumab in hereditary hemorrhagic telangiectasia - Bevazizumab in HHT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-018049-19-AT

Enrollment

Registered

2010-11-23

Start date

2010-12-13

Completion date

Unknown

Last updated

2014-05-12

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

Conditions

epistaxis

Interventions

Trade Name: AVASTIN 25 mg/ml - Konzentrat zur Herstellung einer Infusionsloesung Pharmaceutical Form: Solution for injection INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration unit

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosed HHT (Shovlin et al 2000) Age 18-80 Minimum of 2 episodes of epistaxis/ week Ability and willigness to complete diary and comply with study requirements Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 (<3months) or planned surgery Nasal intervention (Laser or Cautery) in pretreatment phase Allergy to local anaesthetic

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate treatment efficacy of intranasal submucosal bevacizumab in comparison to placebo, as measured by relative reduction in average VAS scores of epistaxis ;Secondary Objective: • To assess effects on duration, severity and frequency of epistaxis, • To asses effects on frequency of Emergency department visits including emergency epistaxis measures • To assess differences in treatment in patients with different severity of the disease, • To assess differences in treatment in patients of different age groups, • To assess the effect on laboratory parameters (ferritin, Hb, Hkt) • To assess the effect on frequency of transfusions ;Primary end point(s): • Relative difference in average of daily Epistaxis VAS scores 28 days pretreatment to days 10- 84 post treatment	—

Measure

Time frame

Main Objective: To demonstrate treatment efficacy of intranasal submucosal bevacizumab in comparison to placebo, as measured by relative reduction in average VAS scores of epistaxis ;Secondary Objective: • To assess effects on duration, severity and frequency of epistaxis, • To asses effects on frequency of Emergency department visits including emergency epistaxis measures • To assess differences in treatment in patients with different severity of the disease, • To assess differences in treatment in patients of different age groups, • To assess the effect on laboratory parameters (ferritin, Hb, Hkt) • To assess the effect on frequency of transfusions ;Primary end point(s): • Relative difference in average of daily Epistaxis VAS scores 28 days pretreatment to days 10- 84 post treatment

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Countries

Austria

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026