Infantile HemangiomapostHemangiolNCT04105517
Hemangiol, Post Marketing Surveillance Study
An observational study of Infantile Hemangioma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Infantile hemangioma is a benign tumor belonging to the group of vascular tumors in the ISSVA classification (International Society for the Study of Vascular Anomalies). The diagnosis is clinical and radiological. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Infantile Hemangioma
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to 30 Oct 2019
- Phase
- Observational
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children aged 0 to 1 years hospitalized for introduction of Hemangiol for proliferative infantile hemangiomas.
Who may be able to join
- Child from 0 to 18 years old hospitalized for introduction of Hemangiol between January 2014 and November 2018
Who cannot join
- Patients refuse the use of medical data will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prescription of Hemangiol in the Treatment of Proliferative Infantile Hemangiomas Requiring Systemic Treatment: Post Marketing Surveillance Study
Infantile hemangioma is a benign tumor belonging to the group of vascular tumors in the ISSVA classification (International Society for the Study of Vascular Anomalies). The diagnosis is clinical and radiological. The hemangioma appears during the first weeks of life (70% classically within 2 weeks after birth) but can, when it develops in the subcutaneous tissue, appear until the age of 2 to 3 months .
Its evolution is characteristic and is divided into 3 phases with a proliferative phase characterized by a rapid increase in the size of the tumor (up to 6 to 12 months), a phase of stabilization (from 12 to 36 months) with a stopping of the growth of the hemangioma and a regression of its size and a phase of involution with the disappearance of the lesion which may give way to residual fibroadipose tissue, cutaneous telangiectases, scars … The usual complications of haemangiomas occur during the proliferative phase. It is necrosis, ulcerations that can be complicated by bleeding or infection and eventually indelible scarring. Other complications related to the site of development of hemangiomas (amblyopia, astigmatism, upper respiratory obstruction, nasal obstruction, sphincter disorders, eating disorders), hemangiomas destroying structures noble (breast hypodévelopment, alopecia). The aesthetic prognosis can be seriously compromised for facial locations.
Read more
Historically, when drug therapy was required, patient management was based on systemic corticosteroids (at doses of 3 to 5 mg / kg / day) in first-line therapy and vincristine as a second-line failure of corticosteroid therapy or when life-threatening is at stake.
In 2014, the high French health authority (HAS) gave Marketing Authorization for Hemangiol 3.75 mg / ml oral solution for the management of infantile proliferative hemangioma requiring first-line systemic treatment, evaluating the actual benefit as important.
The selected indication concerns children from 5 weeks to 5 months with:
- Hemangiomas leading to a vital or functional risk,
- Hemangiomas ulcerated painful and / or not responding to simple care,
- Hemangiomas with a risk of permanent scarring or disfigurement. The 2014 HAS Transparency Commission wishes in its report "to have follow-up data of prescriptions allowing to describe on a representative sample of patients, the characteristics of the treated patients, the indication, the doses and the durations of treatment of this specialty ".
The objective of our study is to describe the use of Hemangiol in current practice in our hospital from 2014 to 2018.
Read the detailed description
This study is retrospective, longitudinal, descriptive and observational. Children aged 0 to 1 years hospitalized for introduction of Hemangiol between January 2014 and November 2018 will be included. Patients refuse the use of medical data will be excluded.
The main objective is to describe the population who received Hemangiol. The secondary objectives is to evaluate
- the effectiveness of Hemangiol on proliferative infantile hemangiomas, -the tolerance of Hemangiol in children with proliferative infantile hemangiomas
- the interest of systematic cardiological consultation in children with proliferative infantile hemangiomas receiving Hemangiol
The following criteria will be collected
Demographic description: age, sex, height, weight
Personal history
Description of the hemangioma:
- organ concerned: skin, liver, parotid, mixed.
- location: head, thorax, pelvis, limbs, diffuse ...
- single or multiple
- indication of treatment: aesthetic, functional, ulcerated, cardiac hyperacidity
Rhythm of follow-up: duration of treatment and observance of treatment
Prescribed dose: 1, 2, 3 or 4 mg / kg / day in 2 doses
Evolution of the hemangioma: progression, regression, stagnation. Needed a second medical therapeutic line by specifying the treatment introduced. Necessity of surgical management by specifying the delay between surgery and the introduction of treatment
Description of serious adverse events: hypotension, bradycardia, bronchospasm, hypoglycaemia. Description of other adverse events.
Number of cardio-pediatric consultations, specifying:
- incidence of diagnosed heart disease through systematic cardiac consultation
- effect on ECG data of increasing dosage of Hemangiol: heart rate, PR duration, QRS duration, QT duration
- Conditions
- Infantile Hemangioma
- Keywords
- Proliferative infantile hemangiomas, Hemangiol, Propranolol
- Medical subject headings
- Hemangioma, Capillary
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events in children with proliferative infantile hemangiomas receiving Hemangiol
- rate serious adverse events: hypotension, bradycardia, bronchospasm, hypoglycemia
- rate of adverse events
Measured: 6 days
Secondary outcomes (2)
Incidence of the regression of proliferative infantile hemangiomas in children receiving Hemangiol
rate of regression of the hemangioma
- rate of need for a second therapeutic medical line
- rate of need for surgical management
Measured: 6 days
Incidence of diagnosed heart diseases with systematic cardiac consultation events in children with proliferative infantile hemangiomas receiving Hemangiol
rate of diagnosed heart disease
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2019
- Study start1 Jul 2019
- Primary completion20 Oct 2019
- Study completion30 Oct 2019
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 Infantile HemangiomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arthur GAVOTTO, MD, Principal investigator, University Hospital, MontpellierPascal AMEDRO, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04105517
- Sponsor's protocol ID
- RECHMPL19_0402
- Acronym
- postHemangiol
- Status last verified
- Nov 2020
- First submitted
- 18 Sep 2019
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Publications
Socchi F, Bigorre M, Normandin M, Captier G, Bessis D, Mondain M, Blanchet C, Akkari M, Amedro P, Gavotto A. Hemangiol in infantile haemangioma: A paediatric post-marketing surveillance drug study. Br J Clin Pharmacol. 2021 Apr;87(4):1970-1980. doi: 10.1111/bcp.14593. Epub 2020 Nov 16.
PubMed 33118199
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prescription of Hemangiol in the Treatment of Proliferative Infantile Hemangiomas Requiring Systemic Treatment: Post Marketing Surveillance Study
- ClinicalTrials.gov ID
- NCT04105517
- Acronym / sponsor ID
- postHemangiol / RECHMPL19_0402
- Conditions
- Infantile Hemangioma
- Keywords
- Proliferative infantile hemangiomas, Hemangiol, Propranolol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 20 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 26 Sep 2019 (actual)
- 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.
Infantile hemangioma is a benign tumor belonging to the group of vascular tumors in the ISSVA classification (International Society for the Study of Vascular Anomalies). The diagnosis is clinical and radiological. The hemangioma appears during the first weeks of life (70% classically within 2 weeks after birth) but can, when it develops in the subcutaneous tissue, appear until the age of 2 to 3 months .
Its evolution is characteristic and is divided into 3 phases with a proliferative phase characterized by a rapid increase in the size of the tumor (up to 6 to 12 months), a phase of stabilization (from 12 to 36 months) with a stopping of the growth of the hemangioma and a regression of its size and a phase of involution with the disappearance of the lesion which may give way to residual fibroadipose tissue, cutaneous telangiectases, scars … The usual complications of haemangiomas occur during the proliferative phase. It is necrosis, ulcerations that can be complicated by bleeding or infection and eventually indelible scarring. Other complications related to the site of development of hemangiomas (amblyopia, astigmatism, upper respiratory obstruction, nasal obstruction, sphincter disorders, eating disorders), hemangiomas destroying structures noble (breast hypodévelopment, alopecia). The aesthetic prognosis can be seriously compromised for facial locations.
Historically, when drug therapy was required, patient management was based on systemic corticosteroids (at doses of 3 to 5 mg / kg / day) in first-line therapy and vincristine as a second-line failure of corticosteroid therapy or when life-threatening is at stake.
In 2014, the high French health authority (HAS) gave Marketing Authorization for Hemangiol 3.75 mg / ml oral solution for the management of infantile proliferative hemangioma requiring first-line systemic treatment, evaluating the actual benefit as important.
The selected indication concerns children from 5 weeks to 5 months with:
- Hemangiomas leading to a vital or functional risk,
- Hemangiomas ulcerated painful and / or not responding to simple care,
- Hemangiomas with a risk of permanent scarring or disfigurement. The 2014 HAS Transparency Commission wishes in its report "to have follow-up data of prescriptions allowing to describe on a representative sample of patients, the characteristics of the treated patients, the indication, the doses and the durations of treatment of this specialty ".
The objective of our study is to describe the use of Hemangiol in current practice in our hospital from 2014 to 2018.
Detailed description
This study is retrospective, longitudinal, descriptive and observational. Children aged 0 to 1 years hospitalized for introduction of Hemangiol between January 2014 and November 2018 will be included. Patients refuse the use of medical data will be excluded.
The main objective is to describe the population who received Hemangiol. The secondary objectives is to evaluate
- the effectiveness of Hemangiol on proliferative infantile hemangiomas, -the tolerance of Hemangiol in children with proliferative infantile hemangiomas
- the interest of systematic cardiological consultation in children with proliferative infantile hemangiomas receiving Hemangiol
The following criteria will be collected
Demographic description: age, sex, height, weight
Personal history
Description of the hemangioma:
- organ concerned: skin, liver, parotid, mixed.
- location: head, thorax, pelvis, limbs, diffuse ...
- single or multiple
- indication of treatment: aesthetic, functional, ulcerated, cardiac hyperacidity
Rhythm of follow-up: duration of treatment and observance of treatment
Prescribed dose: 1, 2, 3 or 4 mg / kg / day in 2 doses
Evolution of the hemangioma: progression, regression, stagnation. Needed a second medical therapeutic line by specifying the treatment introduced. Necessity of surgical management by specifying the delay between surgery and the introduction of treatment
Description of serious adverse events: hypotension, bradycardia, bronchospasm, hypoglycaemia. Description of other adverse events.
Number of cardio-pediatric consultations, specifying:
- incidence of diagnosed heart disease through systematic cardiac consultation
- effect on ECG data of increasing dosage of Hemangiol: heart rate, PR duration, QRS duration, QT duration
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children aged 0 to 1 years hospitalized for introduction of Hemangiol for proliferative infantile hemangiomas.
Key inclusion criteria (1 listed)
- Child from 0 to 18 years old hospitalized for introduction of Hemangiol between January 2014 and November 2018
Key exclusion criteria (1 listed)
- Patients refuse the use of medical data will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of adverse events in children with proliferative infantile hemangiomas receiving Hemangiol
Time frame: 6 days
* rate serious adverse events: hypotension, bradycardia, bronchospasm, hypoglycemia * rate of adverse events
2 secondary outcomes
Incidence of the regression of proliferative infantile hemangiomas in children receiving Hemangiol
Time frame: 6 days
Incidence of diagnosed heart diseases with systematic cardiac consultation events in children with proliferative infantile hemangiomas receiving Hemangiol
Time frame: 3 days
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 2 Dec 2020.
- Results publication: PubMed 33118199Socchi F, Bigorre M, Normandin M, Captier G, Bessis D, Mondain M, Blanchet C, Akkari M, Amedro P, Gavotto A. Hemangiol in infantile haemangioma: A paediatric post-marketing surveillance drug study. Br J Clin Pharmacol. 2021 Apr;87(4):1970-1980. doi: 10.1111/bcp.14593. Epub 2020 Nov 16.
- Individual participant dataSharing planned: Undecided. NC
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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.
Arthur GAVOTTO, MD principal investigator
University Hospital, Montpellier
Pascal AMEDRO, MD, PhD study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infantile Hemangioma, run by University Hospital, Montpellier at 1 site 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 1 inclusion and 1 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 2 Dec 2020. 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 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.
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?
Incidence of adverse events in children with proliferative infantile hemangiomas receiving Hemangiol (time frame: 6 days). 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 NCT04105517, 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 2 Dec 2020.