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    The EU Clinical Trials Register currently displays   44138   clinical trials with a EudraCT protocol, of which   7324   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:2013-002847-28
    Sponsor's Protocol Code Number:CRLX030A2208
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-04-28
    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 ConcernedGermany - BfArM
    A.2EudraCT number2013-002847-28
    A.3Full title of the trial
    Multicenter, open-label, dose escalation study to evaluate safety, tolerability and pharmacokinetics of RLX030 in addition to standard of care in pediatric patients from birth to <18 years of age, hospitalized with acute heart failure.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Pharmacokinetic and safety of serelaxin when added to standard of care in pediatric patients hospitalized with acute heart failure
    A.4.1Sponsor's protocol code numberCRLX030A2208
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/292/2016
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Pharma GmbH - Medizinischer Infoservice
    B.5.2Functional name of contact pointMedical Competence Center
    B.5.3 Address:
    B.5.3.1Street AddressRoonstrasse 25
    B.5.3.2Town/ cityNürnberg
    B.5.3.3Post code90429
    B.5.3.4CountryGermany
    B.5.4Telephone number+411802232300
    B.5.5Fax number+4991127312160
    B.5.6E-mailinfoservice.novartis@novartis.com
    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 nameserelaxin
    D.3.2Product code RLX030
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSERELAXIN
    D.3.9.1CAS number Not establis
    D.3.9.2Current sponsor codeRLX030
    D.3.9.3Other descriptive nameRLX030
    D.3.9.4EV Substance CodeSUB119779
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1.0
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 Yes
    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
    acute heart failure
    E.1.1.1Medical condition in easily understood language
    acute heart failure
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10000803
    E.1.2Term Acute heart failure
    E.1.2System Organ Class 100000004849
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - evaluate the safety and tolerability of an iv serelaxin infusion in addition to standard of care in hospitalized pediatric patients with AHF.
    - investigate the effects of age on the pharmacokinetics of serelaxin given as iv infusion in addition to standard of care in hospitalized pediatric patients with AHF
    E.2.2Secondary objectives of the trial
    To evaluate the hemodynamic effects of different doses of serelaxin given as an iv infusion in addition to standard of care in hospitalized pediatric patients with AHF [efficacy parameters: arterial blood pressure, left atrial pressure (LAP), pulmonary artery pressure (PAP – systolic and diastolic), central venous and arterial oxygen saturation, urine output, and blood lactate levels].
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Investigation of possible correlations between the serelaxin exposure and PD effects through high-frequency data of continuously monitored clinical and hemodynamic parameters. (dated 20 August 2014, version 1)

    Exploratory Objectives
    • To explore the serelaxin PK-PD relationship using high-frequency data from patients enrolled in sites participating in the high-frequency data sub-study
    • To explore the benefits, feasibility and resource requirements of automated high-frequency
    E.3Principal inclusion criteria
    1. Written informed consent by parent(s)/legal guardian(s) for the pediatric patient must be obtained before any study-specific assessment is performed
    2. Male or female, birth to <18 years of age, with body weight ≥2.5 kg to ≤120 kg
    3. Hospitalized in an intensive/critical care unit or continuously monitored step-down unit with the following:
    a) signs and symptoms of AHF of any etiology
    b) a stable dose of vasoactive and/or inotropic agents
    c) for non-surgical patients (medical etiologies of AHF), echocardiographic evidence of reduced ventricular function is required as follows:
    i.Ejection fraction of the systemic or pulmonary ventricle <50% in patients with systemic left ventricular dysfunction, or
    ii.Fractional shortening <28% in patients with systemic left ventricular dysfunction, or
    iii.Qualitative evidence of a dilated ventricle with at least mild systemic ventricular systolic dysfunction in patients with right ventricular or single ventricular physiology
    4. Systolic blood pressure (SBP) consistently equal to or greater than the calculated 25th percentile SBP for age and gender per the protocol.
    5. Stable pulmonary function, i.e. patient is extubated or is stable on ventilator support.

    Additional details are listed in the clinical study protocol.
    E.4Principal exclusion criteria
    1. Hypovolemia
    2. Moderate to severe left ventricular outflow tract (including sub-valvular, valvular and supra-valvular), mitral stenosis or aortic arch obstruction
    3. Patients with single ventricle physiology before their Fontan operation
    (However, single ventricle patients post Glenn operation before their Fontan/Total cavopulmonary connection procedure (TCPC) can be enrolled.)
    4. Patients on ECMO or VAD
    5. Patients with fixed pulmonary hypertension
    6. Patients with blood lactate levels >5 mmol/L at screening
    7. Birth < 36 weeks post-conceptual age (applies only to children <1year old at baseline)
    8. Confirmed or clinically suspected systemic infection (sepsis) or severe localized infection requiring iv antibiotics
    9. Dyspnea or acute lung injury primarily due to non-cardiac causes
    10. Patients with severe renal impairment, those known to have significant renal disease and those having current or planned renal replacement therapy
    11. Excessive use of inotropic and/or vasoactive agents at screening (vasoactive score >20)
    12. Current or planned use of the following concomitant medications during the duration of the study drug infusion: levosimendan, nesiritide
    13. History or current diagnosis of cardiac electrocardiographic abnormalities
    14. Any major solid organ transplant recipient within 1 year of transplantation
    15. Any major solid organ transplant recipient who presents with severe organ rejection
    E.5 End points
    E.5.1Primary end point(s)
    - safety and tolerability: rate of adverse events and routine assessment of laboratory parameters including those for renal function
    - PK: Css and CL
    E.5.1.1Timepoint(s) of evaluation of this end point
    -safety and tolerability: during the entire duration of the study
    -PK:
    Children in age cohorts 1-3 (1 month - <18 years): baseline (0), 2, 16, 22, 32, 40, 48 hours; post infusion 0.5, 4, 8 hours and day 28
    Children in age cohort 4 (birth to <1 month): 16, 22, 32, 48 hr; post infusion 0.5, 4, 8 hr and if blood volume will allow, additional samples will be taken during the infusion at baseline, 2 and 40 hr and post infusion at day 28.
    E.5.2Secondary end point(s)
    arterial BP and central venous pressure (CVP), left atrial pressure (LAP), pulmonary artery pressure (PAP – systolic and diastolic), central venous and arterial oxygen saturation, urine output and blood lactate levels.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at baseline, prior to each dose escalation and at approximately 24 hours after the end of the infusion
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Switzerland
    United Kingdom
    United States
    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
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    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.1.1Number of subjects for this age range: 30
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Yes
    F.1.1.2.1Number of subjects for this age range: 2
    F.1.1.3Newborns (0-27 days) Yes
    F.1.1.3.1Number of subjects for this age range: 7
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 12
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 9
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 6
    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 Yes
    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
    pediatric patients
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 18
    F.4.2.2In the whole clinical trial 30
    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)
    investigator must provide follow-up medical care for all patients who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care
    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 Decision2014-05-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-04-03
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