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    The EU Clinical Trials Register currently displays   42570   clinical trials with a EudraCT protocol, of which   7009   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).


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    Summary
    EudraCT Number:2010-023488-16
    Sponsor's Protocol Code Number:V00400SB301
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-12-16
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2010-023488-16
    A.3Full title of the trial
    A multicentre, open-label study of propranolol in infants with proliferating infantile hemangioma requiring systemic therapy
    A.4.1Sponsor's protocol code numberV00400SB301
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPIERRE FABRE DERMATOLOGIE represented by INSTITUT DE RECHERCHE PIERRE FABRE
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameV0400SB07
    D.3.2Product code V0400SB07
    D.3.4Pharmaceutical form Oral solution
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROPRANOLOL
    D.3.9.1CAS number 525-66-6
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.75
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Proliferating Infantile Hemangioma
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10018814
    E.1.2Term Haemangioma
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    No secondary objectives
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last follow-up visit of the last patient
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months56
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Infants
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state70
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Already provided in the protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-02-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-12
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