A multicentre, open-label study of propranolol in infants with proliferating infantile hemangioma requiring systemic therapy

Phase 1

• Conditions: MedDRA version: 12.1Level: LLTClassification code 10018814Term: Haemangioma; Proliferating Infantile Hemangioma

• Registration Number: EUCTR2010-023488-16-FR
• Lead Sponsor: PIERRE FABRE DERMATOLOGIE represented by INSTITUT DE RECHERCHE PIERRE FABRE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-16
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

A patient will be eligible if he/she meets all of the following criteria:
• Patient having been treated and having completed the end of study visit of the study V00400 SB 102 or the study V00400 SB 201 within the previous 6 months
• Written informed consent(s) for study participation are obtained according to National regulations from the patient’s parent(s) or guardian(s) prior to performing any study procedures
• Proliferating IH requiring systemic therapy with propranolol in the investigator’s opinion.
• If required by national regulation, registered with a social security or health insurance system and/or whose parent(s) or guardian(s) is(are) registered with a social security or health insurance system

Are the trial subjects under 18? yes
Number of subjects for this age range:
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

A patient will be ineligible if he/she meets any of the following criteria:
• Any patient for whom the medical status has changed since the inclusion in the previous studies, V00400 SB 102 or V00400 SB 201, to a medically unstable health status that may interfere with his/her ability to complete the study
• Patient in whom any event observed in the previous study would, in the investigator’s opinion, preclude the use of propranolol
• The patient presents one or more of the following medical conditions:
bronchial asthma; bronchospasm; hypoglycaemia (< 40 mg/dl or at risk); untreated phaeochromocytoma; hypotension (< 50/30 mmHg); second or third degree heart block; cardiogenic shock; metabolic acidosis; bradycardia (< 80 bpm); severe peripheral arterial circulatory disturbances; Raynaud’s phenomenon; sick sinus syndrome; uncontrolled heart failure or Prinzmetal’s angina; cardiomyopathy; arrhythmia disorder.
• The patient (and/or the mother if she is breastfeeding the patient) has received at least one of the following prohibited medications within 14 days before study treatment administration:
- Anesthetic agents, lidocaine
- Cardiovascular treatments: anti-arrhythmics, calcium channel blockers, ACE inhibitors, inotropic agents, vasodilators (hydralazine hydrochloride…), clonidine…
- Hypoglycaemic agents or drugs able to induce hypoglycaemia
- Inducers of hepatic drug metabolism or substrates or inhibitors of CYP2D6, CYP1A2,CYP2C19
- Anti-ulcer drugs (cimetidine, ranitidine, proton pomp inhibitors other than omeprazole and lanzoprazole)
- Metoclopramide
- Sympathomimetic agents and parenteral adrenaline
- Non-steroid anti-inflammatory drugs (NSAIDs) at anti-inflammatory dose
- Benzodiazepines
- Neuroleptic drugs (chlorpromazine, sultopride hydrochloride…)
- Other drugs: triptans, ergotamine, theophylline, warfarin, thyroxine, floctafenine
• The patient (and/or the mother if she is breastfeeding the patient) is treated with beta-blockers (including propranolol)
• The patient is known to have a hypersensitivity to propranolol and/or any other beta-blockers and/or any ingredient of the test product
• The patient has previously experienced an anaphylactic reaction
• Diagnosis of the soft tissue tumour as IH is not clinically certain, particularly in the case of sub-dermal lesions
• The patient is participating in another clinical study or has received treatment with known remnant effects or undergone investigation liable to interfere with the present clinical trial.
• Parent(s) or guardian(s) cannot be contacted by telephone in case of emergency

Study & Design

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