Proliferating Infantile Hemangioma MedDRA version: 12.1 Level: LLT Classification code 10018814 Term: Haemangioma
Conditions
Interventions
Product Name: V0400SB07
Product Code: V0400SB07
Pharmaceutical Form: Oral solution
INN or Proposed INN: PROPRANOLOL
CAS Number: 525-66-6
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
PIERRE FABRE DERMATOLOGIE represented by INSTITUT DE RECHERCHE PIERRE FABRE
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this study is to allow the use of propranolol with adequate conditions of administration and follow up in infants judged as requiring this systemic treatment after participation to a previous trial. As requested in such conditions, the safety profile (included any potential long term impact) and the effect on the resolution of target proliferating IH will be documented.;Secondary Objective: No secondary objectives;Primary end point(s): Evaluation criterion: Safety criteria: The safety assessments correspond to usual precautions for the initiation and follow-up when treating an infant with a beta-blocker. These safety assessments aim primarily at ensuring participants safety. Safety endpoints will be based on the following evaluations: • Adverse events, height, weight, head circumference, temperature, heart rate, blood pressure, respiratory rate, pulmonary auscultation, liver palpation and global physical examinations (all visits) • ECG measurements (D0, D7, D14, possibly D21, W12, W24) • Neurodevelopment evaluations (D0, W12, W24, W48 and W96) Note that immediately after each ECG review, the investigator must check whether or not there are any clinically significant abnormalities that require the study treatment to be permanently discontinued (or in the case of any doubt in terms of patient safety). Evaluation of the evolution of the hemangioma The evaluation of the evolution of the target hemangioma aims at ensuring adequate medical follow-up of the patient and ensuring proper assessment of the individual benefit/risk ratio in any given participant. • Investigator qualitative assessments compared to baseline: target hemangioma evolution (4-points scale: complete resolution, improvement, stabilisation, worsening) • Assessments of target IH complications: functional impairment/ulceration/haemorrhaging • Categorical endpoints based on whether or not invasive procedures were carried out during the study for target IH. | — |
Countries
France
Outcome results
None listed