NCT01314274

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 12, 2013

Status Verified

August 1, 2013

Enrollment Period

2.3 years

First QC Date

March 9, 2011

Last Update Submit

August 8, 2013

Conditions

HHTMorbus OslerEpistaxis

Keywords

EpistaxisOslerWeberRenduHHTHereditary haemorrhagic telangiectasia

Outcome Measures

Primary Outcomes (1)

  • relative change in average daily Epistaxis VAS scores compared to baseline

    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.

    day 10 - 84 posttreatment

Secondary Outcomes (6)

  • Epistaxis Severity Score HHT-ESS compared to baseline

    3 months post treatment

  • 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

  • lab results (ferritin values, Hb, Hct) compared to baseline

    day 84 posttreatment

  • Number of transfusions needed compared to baseline

    day 10-84 posttreatment

  • +1 more secondary outcomes

Study Arms (2)

bevacizumab

EXPERIMENTAL

submucosal intranasal bevacizumab on day 0

Drug: Bevacizumab

placebo

PLACEBO COMPARATOR

0.9% NaCl intranasal submucosal on day 0

Drug: NaCl

Interventions

BevacizumabDRUG

100mg intranasal submucosal bevacizumab in 10ml

bevacizumab
NaClDRUG

10ml of 0.9% NaCl intranasal submucosal

placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinik für HNO, Medizinische Univeristät Wien

Vienna, 1090, Austria

Location

Related Publications (1)

  • Riss D, Burian M, Wolf A, Kranebitter V, Kaider A, Arnoldner C. Intranasal submucosal bevacizumab for epistaxis in hereditary hemorrhagic telangiectasia: a double-blind, randomized, placebo-controlled trial. Head Neck. 2015 Jun;37(6):783-7. doi: 10.1002/hed.23655. Epub 2014 Apr 30.

    PMID: 24595923DERIVED

MeSH Terms

Conditions

EpistaxisTelangiectasia, Hereditary Hemorrhagic

Interventions

Bevacizumab

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsHemostatic DisordersVascular DiseasesCardiovascular DiseasesTelangiectasisHemorrhagic DisordersHematologic DiseasesHemic and Lymphatic DiseasesVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Martin Burian

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 14, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 12, 2013

Record last verified: 2013-08

Locations

AU(1)