Efficacy and safety of Hemangiol solution in the treatment of high risk infantile hemangioma. A Multinational Single Arm Study

Phase 1

• Conditions: High risk infantile haemangioma; MedDRA version: 17.1Level: PTClassification code 10018814Term: HaemangiomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-005555-80-ES
• Lead Sponsor: Pierre Fabre Dermatologie represented by IRPF

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04-14
• Last Update Posted: 13 March 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Age 35-150 days old inclusive, also subject born prematurely but of his/her term equivalent age at inclusion (corrected age)
2. High risk IH in proliferative phase (target hemangioma):
- life-threatening IH
- peri-orbital, nasal, labial, laryngo-tracheal, limb joints IHs with functional impact or at risk of functional impact
- disfiguring IH (IH > 5cm, glabella location, nasal location, philtrum location, central chin location, central cheek location, labial IH with mouth deformities)
- ulcerated IH not responding to simple wound care measures, located anywhere on the body
3. If required by national regulations, registered with a social security or health insurance system and/or whose parent(s) or legal guardian(s) was (were) registered with a social security or health insurance system
4. Written informed consent(s) for study participation and the use of the subject?s images obtained according to national regulations from the subject?s parent(s) or guardian(s) prior to performing any study procedures
Are the trial subjects under 18? yes
Number of subjects for this age range: 45
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

5. Medically unstable health status that may interfere with his/her ability to complete the study, especially acute broncho-pulmonary abnormality
6. Presence of one or more of the following medical conditions:
- Congenital hemangioma
- Kasabach-Merritt syndrome
- PHACE syndrome
- Hepatic hemangioma
- Asthma
- History of bronchospasm
- At risk of hypoglycaemia according to the medical file of the subject
- Phaeochromocytoma
- Hypotension (SBP/DBP <65/45 mmHg for age 35-90 days, < 70/50 mmHg for age 91-150 days)
- Second or third degree heart block
- Cardiogenic shock
- Bradycardia (HR < 100 bpm for age 35-90 days, < 90 bpm for age 91-150 days)
- Severe peripheral arterial circulatory disturbances, Raynaud?s phenomenon
- Disease of the sinus node (including sinoatrial block)
- Uncontrolled heart failure
- Prinzmetal?s angina
- Hepatic and/or renal impairment
- Psoriasis
7. Kaliemia > 5.0 mmol/L (only measured for subjects presenting an IH with ulcerated area >= 3 cm)
8. Subject?s target hemangioma treated by LASER therapy within the past month,
9. The subject (and/or the mother if she is breastfeeding the subject) has received at least one of the following prohibited medications within 14 days before first study drug administration:
- Corticosteroids by systemic (oral, intra-venous or intra-muscular), intra-lesional or topical route
- Imiquimod
- Vincristine
- Alfa-interferon
- Propranolol or other beta-blockers
- Cardiovascular treatments:
. bradycardia-inducing calcium channel blockers (diltiazem, verapamil, bepridil),
. anti-arrhythmics (propafenone, quinidine, amiodarone, lidocaine),
. inotropic agents (digitalis glycosides),
. dihydropyridines (amlodipine, felodipine, isradipine, lacidipine, lercanidipine, manidipine, nicardipine, nifedipine, nitrendipine, etc?),
. antihypertensives (ACE Inhibitors, angiotensin II-receptors antagonists, diuretics, alpha-blockers whatever the indication, centrally-acting antihypertensives, reserpine, etc?)
- Drugs inducing orthostatic hypotension (nitrates derivatives, type 5-phosphodiesterase inhibitors, tricyclic antidepressants, antipsychotics, dopaminergic agonists, levodopa, amifostine, baclofen, etc?)
- Non-steroid anti-inflammatory drugs (NSAIDs) at anti-inflammatory dose
- Enzyme inducers (rifampicin, phenobarbital,?)
- Hypoglycaemic agents or drugs able to induce hypoglycaemia
- Lipid lowering agents (cholestyramine, colestipol)
- Halogenated anesthetic agents, lidocaine (exclusion period shortened to 48 hours if anaesthesia has been performed for diagnosis investigation, e.g. MRI?)
10. Hypersensitivity to any study drug ingredient
11. Hypersensitivity any beta-blocker
12. Medical history of anaphylactic reaction

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified