Hemangiol, Post Marketing Surveillance Study

NCT04105517 | Completed

• 1 other identifier: RECHMPL19_0402
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infantile Hemangioma

Keywords

Proliferative infantile hemangiomas; Hemangiol; Propranolol

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events in children with proliferative infantile hemangiomas receiving Hemangiol

  * rate serious adverse events: hypotension, bradycardia, bronchospasm, hypoglycemia * rate of adverse events

  6 days

Secondary Outcomes (2)

• Incidence of the regression of proliferative infantile hemangiomas in children receiving Hemangiol

  6 days

• Incidence of diagnosed heart diseases with systematic cardiac consultation events in children with proliferative infantile hemangiomas receiving Hemangiol

  3 days

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children aged 0 to 1 years hospitalized for introduction of Hemangiol for proliferative infantile hemangiomas.

You may qualify if:

• \- Child from 0 to 18 years old hospitalized for introduction of Hemangiol between January 2014 and November 2018

You may not qualify if:

• \- Patients refuse the use of medical data will be excluded.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uh Montpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 33118199 RESULT

MeSH Terms

Conditions

Hemangioma, Capillary

Condition Hierarchy (Ancestors)

Hemangioma; Neoplasms, Vascular Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Arthur GAVOTTO, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

• Pascal AMEDRO, MD, PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 26, 2019
• Study Start: July 1, 2019
• Primary Completion: October 20, 2019
• Study Completion: October 30, 2019
• Last Updated: December 2, 2020

Record last verified: 2020-11

Locations

FR (1)