HemangiomaPhase 3NCT01743885
Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma
A Phase 3 study testing Acebutolol and Propanolol in people with Hemangioma, run by University Hospital, Montpellier at 4 sites in France.
Trial summary
There is no effective treatment for hemangioma regardless of immediate severity. That is in this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of proliferation of several months (very scary for parents) and regression over several years. Read more about this study
- Who is it for?
- Ages Up to 6 months
- Conditions the study is for
- Hemangioma
- What is being tested?
- Acebutolol and Propanolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 4 sitesFrance
- Study dates
- Nov 2012to Jun 2015
- Phase
- Phase 3
- 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 Up to 6 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants under 6 months
- Presenting a hemangioma with the following characteristics:
- subcutaneous and / or cutaneous
- minimum diameter of 1.5cm on face, 5cm outside face and 3cm if it is ulcerated.
- without functional impairment requiring treatment or vital corticosteroid
- Consent of both parents (or the person having parental authority in families)
- Which at least one parent is a beneficiary of a social security system.
Who cannot join
- Indication of treatment with corticosteroids for an indication other than hemangioma
- Indication of treatment with beta-blocker for another indication that the hemangioma
- Infant presenting cons-indications for the administration of acebutolol or propranolol:
- Asthma and chronic obstructive pulmonary disease in their severe forms.
- Heart failure controlled by treatment.
- Cardiogenic shock
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- Prinzmetal Angina
- Bradycardia (<80 beats / min at rest the first month <70/minute from 1 to 6 month).
- Raynaud's phenomenon and peripheral arterial disorders in their severe forms.
- Pheochromocytoma untreated.
- Low blood pressure (blood pressure <60/30 mmHg before 6 months)
- Hypersensitivity to acebutolol or propranolol
- History of anaphylactic reaction.
- Treatment with amiodarone and / or calcium channel blockers.
- Congenital heart disease outside inter auricular communication (CIA) or inter ventricular communication (CIV) insignificant
Trial locations and contacts
4 sites in 1 country.
France4 sites
UH Lyon
Lyon, 69130
UH Marseill
Marseille, 13385
Chirurgy Plastic Department
Montpellier, 34295
UH NCaremeau
Nîmes, 30000
About this study
There is no effective treatment for hemangioma regardless of immediate severity. That is in this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of proliferation of several months (very scary for parents) and regression over several years. The natural history is peppered with local complications (ulcers) and aesthetic and psychological sequelae (sometimes major for the child and the family). The effects of acebutolol and propranolol on the proliferative hemangiomas were discovered accidentally by two French teams (Montpellier for acebutolol and Bordeaux for propranolol). Acebutolol and propranolol have been used for many years for the treatment of hypertension and congenital heart disease, including infants, with few side effects. The effects of acebutolol and propranolol were immediately visible with reduced volume and skin whitening of the hemangioma. In a preliminary study, acebutolol was administered to 20 patients in Montpellier with big regression of hemangiomas. The aim of the study was to compare the clinical efficacy of acebutolol (10mg/Kg/jour) and propranolol (3mg/Kg/j) on the proliferative phase of infantile hemangioma in infants.
- Conditions
- Hemangioma
- Being tested
- Acebutolol, Propanolol
- Keywords
- Hemangioma, Beta-blocker, Acebutolol, Propranolol, Randomized controlled trial, Infants
- Medical subject headings
- Hemangioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcebutololDrug
Also called Sectral
10 mg/kg/jour in 2 doses during 90 days after gradual increase of doses in the first week
PropanololDrug
Also called Syprol
3 mg/kg/jour in 3 doses during 90 days after gradual increase of doses in the first week
| Study group | Role | What they receive |
|---|---|---|
| propanolol | Active comparator | Propanolol (Syprol:oral solution) Receives: Drug: Propanolol |
| Acebutolol | Active comparator | Acebutolol (Sectral:oral solution) Receives: Drug: Acebutolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemangioma size
It will be evaluated using a VAS (visual analogue scale) on a series of photos at Day 0, Day 30 and Day 90
Measured: 3 months
Secondary outcomes (2)
Tolerance of treatment
All adverse events are collected at each visited
Measured: 3 months
Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemangiomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michèle Bigorre, PH, Principal investigator, UH Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743885
- Sponsor's protocol ID
- 8638
- Status last verified
- May 2016
- First submitted
- 28 Nov 2012
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Propranolol Versus Acebutolol on the Proliferative Phase of Infantile Hemangioma
- ClinicalTrials.gov ID
- NCT01743885
- Acronym / sponsor ID
- 8638
- Conditions
- Hemangioma
- Keywords
- Hemangioma, Beta-blocker, Acebutolol, Propranolol, Randomized controlled trial, Infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 6 Dec 2012 (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.
There is no effective treatment for hemangioma regardless of immediate severity. That is in this respect a orphan disease. These hemangiomas, sometimes large, will have a phase of proliferation of several months (very scary for parents) and regression over several years. The natural history is peppered with local complications (ulcers) and aesthetic and psychological sequelae (sometimes major for the child and the family). The effects of acebutolol and propranolol on the proliferative hemangiomas were discovered accidentally by two French teams (Montpellier for acebutolol and Bordeaux for propranolol). Acebutolol and propranolol have been used for many years for the treatment of hypertension and congenital heart disease, including infants, with few side effects. The effects of acebutolol and propranolol were immediately visible with reduced volume and skin whitening of the hemangioma. In a preliminary study, acebutolol was administered to 20 patients in Montpellier with big regression of hemangiomas. The aim of the study was to compare the clinical efficacy of acebutolol (10mg/Kg/jour) and propranolol (3mg/Kg/j) on the proliferative phase of infantile hemangioma in infants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| propanolol | Active comparator | Drug: PropanololPropanolol (Syprol:oral solution) |
| Acebutolol | Active comparator | Drug: AcebutololAcebutolol (Sectral:oral solution) |
Who may qualify
- Ages
- Up to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infants under 6 months
- Presenting a hemangioma with the following characteristics:
- Consent of both parents (or the person having parental authority in families)
- Which at least one parent is a beneficiary of a social security system.
Key exclusion criteria (15 listed)
- Indication of treatment with corticosteroids for an indication other than hemangioma
- Indication of treatment with beta-blocker for another indication that the hemangioma
- Infant presenting cons-indications for the administration of acebutolol or propranolol:
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 |
|---|---|---|
| AcebutololAlso: Sectral10 mg/kg/jour in 2 doses during 90 days after gradual increase of doses in the first week | Drug | Acebutolol |
| PropanololAlso: Syprol3 mg/kg/jour in 3 doses during 90 days after gradual increase of doses in the first week | Drug | propanolol |
Primary outcome
Hemangioma size
Time frame: 3 months
It will be evaluated using a VAS (visual analogue scale) on a series of photos at Day 0, Day 30 and Day 90
2 secondary outcomes
Tolerance of treatment
Time frame: 3 months
Proportion of patients requiring treatment with corticosteroids because of the evolution of a 'serious' hemangioma
Time frame: 3 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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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.
Michèle Bigorre, PH principal investigator
UH Montpellier
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acebutolol and Propanolol in people with Hemangioma, run by University Hospital, Montpellier at 4 sites in France.
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 7 inclusion and 15 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: stopped early, as of the sponsor's last update on 1 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early. Results are not available in the source record.
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?
Hemangioma size (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2016.