HHTPhase 2NCT01314274
Intranasal Submucosal Bevacizumab for Epistaxis in Hereditary Hemorrhagic Telangiectasia (HHT)
A Phase 2 study testing Bevacizumab and NaCl in people with HHT and Morbus Osler, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HHT, Morbus Osler, Epistaxis
- What is being tested?
- Bevacizumab and NaCl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteAustria
- Study dates
- Mar 2011to Jun 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site
Universitätsklinik für HNO, Medizinische Univeristät Wien
Vienna, 1090
About this study
Official title: A Randomized Double Blind Placebo Controlled Trial of Intranasal Submucosal Bevacizumab in Hereditary Hemorrhagic Telangiectasia
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.
- Conditions
- HHT, Morbus Osler, Epistaxis
- Being tested
- Bevacizumab, NaCl
- Keywords
- Epistaxis, Osler, Weber, Rendu, HHT, Hereditary haemorrhagic telangiectasia
- Medical subject headings
- Epistaxis, Telangiectasia, Hereditary Hemorrhagic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
100mg intranasal submucosal bevacizumab in 10ml
NaClDrug
10ml of 0.9% NaCl intranasal submucosal
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Experimental | submucosal intranasal bevacizumab on day 0 Receives: Drug: Bevacizumab |
| placebo | Placebo comparator | 0.9% NaCl intranasal submucosal on day 0 Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: day 10 - 84 posttreatment
Secondary outcomes (6)
Epistaxis Severity Score HHT-ESS compared to baseline
Measured: 3 months post treatment
Epistaxis frequency, duration and severity compared to baseline
Measured: day 10 - 84 posttreatment
Number of emergency department visits due to epistaxis compared to baseline
Measured: day 10 - 84 posttreatment
lab results (ferritin values, Hb, Hct) compared to baseline
Measured: day 84 posttreatment
Number of transfusions needed compared to baseline
Measured: day 10-84 posttreatment
Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity
Measured: day 10-84 posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HHTStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Burian, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314274
- Sponsor's protocol ID
- bevacizumab HHT
- Other IDs
- 2009-018049-19, 2009
- Status last verified
- Aug 2013
- First submitted
- 9 Mar 2011
- Last updated
- 12 Aug 2013
- Results posted
- No
Publications
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.
PubMed 24595923
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double Blind Placebo Controlled Trial of Intranasal Submucosal Bevacizumab in Hereditary Hemorrhagic Telangiectasia
- ClinicalTrials.gov ID
- NCT01314274
- Acronym / sponsor ID
- bevacizumab HHT
- Conditions
- HHT, Morbus Osler, Epistaxis
- Keywords
- Epistaxis, Osler, Weber, Rendu, HHT, Hereditary haemorrhagic telangiectasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Experimental | Drug: Bevacizumabsubmucosal intranasal bevacizumab on day 0 |
| placebo | Placebo comparator | Drug: NaCl0.9% NaCl intranasal submucosal on day 0 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab100mg intranasal submucosal bevacizumab in 10ml | Drug | bevacizumab |
| NaCl10ml of 0.9% NaCl intranasal submucosal | Drug | placebo |
Primary outcome
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.
6 secondary outcomes
Epistaxis Severity Score HHT-ESS compared to baseline
Time frame: 3 months post treatment
Epistaxis frequency, duration and severity compared to baseline
Time frame: day 10 - 84 posttreatment
Number of emergency department visits due to epistaxis compared to baseline
Time frame: day 10 - 84 posttreatment
lab results (ferritin values, Hb, Hct) compared to baseline
Time frame: day 84 posttreatment
Number of transfusions needed compared to baseline
Time frame: day 10-84 posttreatment
Average daily epistaxis VAS scores compared to baseline among age groups and among groups with different epistaxis severity
Time frame: day 10-84 posttreatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2013.
- Derived from this study: PubMed 24595923Riss 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab and NaCl in people with HHT and Morbus Osler, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative change in average daily Epistaxis VAS scores compared to baseline (time frame: day 10 - 84 posttreatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01314274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2013.