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    Summary
    EudraCT Number:2013-002781-39
    Sponsor's Protocol Code Number:CRLX030A2209
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-07-21
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-002781-39
    A.3Full title of the trial
    Prospective, Double-Blind, Multicenter Study Evaluating the Safety of Repeat Doses of IV Serelaxin in Subjects with Chronic Heart Failure
    Een multicenter dubbelblind onderzoek naar de veiligheid van herhaalde intraveneuze toedieningen van serelaxin bij patiënten met chronisch hartfalen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of safety of repeat doses of IV serelaxin in subjects with chronic heart failure.
    Een klinische studie naar de veiligheid van herhaalde intraveneuze toedieningen van serelaxin bij patienten met chronisch hartfalen
    A.3.2Name or abbreviated title of the trial where available
    RELAX-REPEAT
    RELAX-REPEAT
    A.4.1Sponsor's protocol code numberCRLX030A2209
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01982292
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    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 Services AG
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressLichtstrasse 35
    B.5.3.2Town/ cityBasel
    B.5.3.3Post code4056
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number+44613241111
    B.5.5Fax number+44613248001
    B.5.6E-mailclinicaltrial.enquiries@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.3.9.2Current sponsor codeRLX030
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    chronic heart failure
    chronisch hartfalen
    E.1.1.1Medical condition in easily understood language
    chronic heart failure
    chronisch hartfalen
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    assess the safety of repeat doses of serelaxin in chronic heart failure
    evalueren van de veiligheid van herhaalde intraveneuze toedieningen van serelaxin bij patienten met chronisch hartfalen
    E.2.2Secondary objectives of the trial
    - assess the incidence rate of adverse events of special interest, indicative of hypersensitivity reactions
    - assess the safety and tolerability of repeated infusions of serelaxin relative to placebo, in subjects with chronic heart failure
    -characterize the pharmacokinetics of serelaxin during and after administration of repeated infusions
    - beoordelen van de incidentie van bijwerkingen die belangrijk zijn en indicatief zijn voor overgevoeligheidsreacties
    - beoordelen van de veiligheid en verdraagbaarheid van herhaalde intraveneuze toedieningen van serelaxin bij patiënten met chronisch hartfalen, in vergelijking met placebo
    - onderzoeken van de farmacokinetiek van serelaxin tijdens en na de herhaalde intraveneuze toedieningen
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Body weight of ≤ 160 kg
    - Subjects with compensated CHF (NYHA Class II – III) at time of screening with a prior documented history of chronic heart failure
    - NT-proBNP >300 pg/ml (according to central measurement) at visit 1
    - Subjects treated with appropriate and guideline-indicated CHF standard of care
    - Ability to comply with all requirements, including ability to receive at least a 48 hour infusion plus follow-up time required for each dosing visit.
    - Lichaamsgewicht van ≤ 160 kg
    - Proefpersonen met gecompenseerd chronisch hartfalen (NYHA klasse II - III) op het moment van screening met een eerder gedocumenteerde geschiedenis van chronisch hartfalen
    - NT-proBNP> 300 pg / ml (volgens de centrale meting) op visite 1
    - Proefpersonen die behandeld worden conform de bestaande richtlijnen voor chronisch hartfalen
    - In staat zijn om te voldoen aan alle protocol vereisten, waaronder de mogelijkheid om op zijn minst een 48 uur durend intraveneus infuus te ontvangen plus nadien in het ziekenhuis te blijven voor een follow-up tijd die nodig is.
    E.4Principal exclusion criteria
    - Current acute decompensated HF
    - Any major solid organ transplant recipient or planned anticipated organ transplant within 1 year
    - Documented history of untreated ventricular arrhythmia with syncopal episodes, ventricular tachycardia, or ventricular fibrillation without ICD (implantable cardioverter defibrillator) with significant
    hemodynamic consequences within the 3 months prior to screening
    - Presence of hemodynamically significant mitral and /or aortic valve disease, except mitral regurgitation secondary to left ventricular dilatation: including significant left ventricular outflow obstruction (e.g., obstructive hypertrophic cardiomyopathy, severe aortic stenosis)
    - Subjects with severe renal impairment defined as prerandomization eGFR < 30 ml/min/1.73m2 calculated using the sMDRD equation and/or those receiving current or planned dialysis or ultrafiltration
    - Huidig acuut gedecompenseerd hartfalen
    - Elke grote solide orgaantransplantatie of geplande / verwachte orgaantransplantatie binnen 1 jaar
    - Gedocumenteerde geschiedenis van een onbehandeld ventriculaire aritmie met episodes van syncope, ventriculaire tachycardie of ventrikelfibrilleren zonder ICD met significante hemodynamische gevolgen binnen de 3 maanden voorafgaand aan de screening
    - Aanwezigheid van hemodynamisch significante mitralisklep en / of aortaklepziekte, behalve mitralis insufficientie secundair aan linker ventrikel dilatatie: inclusief significante linker ventrikel outflow obstructie (zoals, obstructieve hypertrofische cardiomyopathie, ernstige aortastenose)
    - Proefpersonen met ernstige nierinsufficiëntie gedefinieerd als prerandomisatie eGFR <30 ml/min/1.73m2 berekend met de sMDRD vergelijking en / of degenen met huidige of geplande dialyse of ultrafiltratie
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of participants with chronic heart failure who develop anti-serelaxin antibodies following repeat administration of IV continuous infusions of serelaxin up to 48 hours
    Percentage proefpersonen met chronisch hartfalen waarbij serelaxin antilichamen worden gevonden na herhaalde 48 uurs IV toediening van serelaxin
    E.5.1.1Timepoint(s) of evaluation of this end point
    16 weeks
    16 weken
    E.5.2Secondary end point(s)
    - Percentage of participants with chronic heart failure who develop anti-serelaxin antibodies
    - Antibody levels in subjects with chronic heart failure who develop anti-serelaxin antibodies (neutralizing, non-neutralizing or both)
    - Number of patients with adverse events
    - Percentage of participants with chronic heart failure who develop anti-serelaxin antibodies neutralizing or non-neutralizing
    - Pharmacokinetics of RLX030: Area under the plasma concentration time curve from time zero up to 48 hours post dose (AUC 0-48), actual
    concentrations over time,
    - Pharmacokinetics of RLX030: Cmax steady state (Cmaxss) concentration, clearance of serelaxin
    Percentage van de proefpersonen met chronisch hartfalen waarbij serelaxin antilichamen worden gevonden
    - Serelaxin antilichaam titers in proefpersonen met chronisch hartfalen (neutraliserende, niet-neutraliserende of beide)
    - Aantal proefpersonen met bijwerkingen
    - Percentage van de proefpersonen met chronisch hartfalen waarbij serelaxin antilichamen worden gevonden, neutraliserende of niet-neutraliserende.
    - De farmacokinetiek van RLX030: Oppervlakte onder de plasmaconcentratie-tijd curve van tijdstip nul tot 48 uur na dosering(AUC 0-48), werkelijke concentraties gedurende de tijd.
    - De farmacokinetiek van RLX030: Cmax steady state (Cmaxss) concentratie, klaring van serelaxin
    E.5.2.1Timepoint(s) of evaluation of this end point
    - after a single infusion (Week 4), two infusions (Week 8) or three infusions (Week 12) of serelaxin.
    - at any time following 3 repeated infusions and at Week 4, Week 8 and Week 12.
    - 16 Weeks
    - at any time following 3 repeated infusions and at Week 4, Week 8 and Week 12.
    - pre-infusion and 8, 24 and 48 hours post each infusion.
    - 48 hours after every infusion
    - Na een enkele infusie met serelaxin (week 4), twee infusies (week 8) of drie infusies (week 12).
    - Op elk gewenst moment na 3 herhaalde infusies en op tijdstip week 4, week 8 en week 12.
    - 16 weken
    - Op elk gewenst moment na 3 herhaalde infusies en op tijdstip week 4, week 8 en week 12.
    - Pre-infusie (t = 0) en op t = 8, 24 en 48 uur tijdena elke infusie.
    - Op t = 48 uur na aanvang van elke infusie
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarkers
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA32
    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
    Australia
    Finland
    Germany
    Italy
    Netherlands
    Norway
    Romania
    Russian Federation
    Spain
    Sweden
    Turkey
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months4
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    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) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 225
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 127
    F.4.2.2In the whole clinical trial 300
    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 subjects who are prematurely withdrawn from the study, or must refer them for appropriate ongoing care
    Onderzoeker is verantwoordelijk voor de medische zorg voor alle proefpersonen die voortijdig stoppen met de studie, eventueel doorverwijzen voor een passende medische zorg
    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 Decision2014-07-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-09-09
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-09-23
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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