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    Summary
    EudraCT Number:2013-002513-35
    Sponsor's Protocol Code Number:CRLX030A3301
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2014-02-14
    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 ConcernedPortugal - INFARMED
    A.2EudraCT number2013-002513-35
    A.3Full title of the trial
    A multicenter, prospective, randomized, open label study to assess the effect of serelaxin versus standard of care in acute heart failure (AHF) patients.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Effect of serelaxin versus standard of care in acute heart failure (AHF) patients.
    A.3.2Name or abbreviated title of the trial where available
    RELAX AHF_Pan EU
    A.4.1Sponsor's protocol code numberCRLX030A3301
    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 Farma - Produtos Farmacêuticos, S.A.
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Professor Doutor Cavaco Silva, nº10E
    B.5.3.2Town/ cityPorto Salvo
    B.5.3.3Post code2740-255
    B.5.3.4CountryPortugal
    B.5.4Telephone number+351 21 000 86 00
    B.5.5Fax number+351 21 000 88 25
    B.5.6E-mailensaios.clinicos@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
    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.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluate the time to in-hospital Worsening of Heart Failure (WHF) requiring rescue therapy/all cause death.
    E.2.2Secondary objectives of the trial
    - Evaluate the Time to in-hospital WHF requiring rescue therapy/all cause death/readmission.
    - Evaluate the percentage of patients with persistent signs or symptoms of HF/ non-improvement
    - Evaluate the percentage of patients with renal deterioration.
    - Evaluate the length of stay.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Explore biomarkers changes
    - Better understand the beneficial effects of serelaxin
    - Monitor patient's response to therapy
    2. Plasma proteome analysis Impact of serelaxin in addition to SOC vs. SOC alone on the changes in plasma proteome at day 5 vs baseline
    3. Nitric Oxide Sub-study
    - Explore and elucidate the effect on the Nitric Oxide (NO) pathway of a 48 hours intravenous administration of serelaxin or the SOC at D2 (48 hours) compared to baseline (0 hours).
    E.3Principal inclusion criteria
    - Male or female ≥ 18 years of age with body weight ≥ 40 Kg and ≤ 160 Kg
    - Systolic blood pressure ≥125 mmHg ate the beggining of the screening period (after ICF signature) and at the end of the screening period (prior to randomization)
    - Admitted for AHF: Persistent dyspnea at rest or with minimal exertion, Pulmonary congestion assessed through physical examination and chest X-Ray
    - Furosemide at any time between admission and the start of screening
    - eGFR on admission: ≥25 and ≤75 mL/min/1.73 m2
    - BNP ≥500 pg/mL or N-terminal pro b-type natriuretic peptide (NT-proBNP)≥2,000 pg/mL

    Other protocol-defined inclusion criteria may apply.
    E.4Principal exclusion criteria
    - Dyspnea (non-cardiac causes) such as acute or chronic respiratory disorders or infections (i.e., severe chronic obstructive pulmonary disease, bronchitis, pneumonia), or primary pulmonary hypertension sufficient to cause dyspnea at rest, which may interfere with the ability to interpret the primary cause of dyspnea.
    - T >38.5°C
    - Clinical evidence of acute coronary syndrome
    - AHF due to arrhythmias, acute myocarditis or cardiomyopathy
    - Known history of respiratory disorders requiring the daily use of IV steroids (does not include inhaled or oral steroids) at least 2 months prior to randomization; need for intubation or the current use of IV steroids for COPD
    - Patients with systolic blood pressure > 180 mmHg at end of screening or persistent heart rate >130 bpm
    - History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year

    Other protocol-defined exclusion criteria may apply.
    E.5 End points
    E.5.1Primary end point(s)
    - Time to in-hospital Worsening of heart failure (WHF) requiring rescue therapy or all cause death through Day 5 post randomization.
    - Time will be computed in hours from randomization to the earlier of the events.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Through Day 5 post randomization
    E.5.2Secondary end point(s)
    - Time to in-hospital Worsening of heart failure requiring rescue therapy as defined in the primary endpoint, or all cause of death or readmission for heart failure. Time will be computed in hours from randomization to the earlier of the events.
    - Percentage of patients with persistent symptoms or signs of Heart Failure / not showing an improvement versus baseline conditions (persisting need of IV therapy for HF).
    - Percentage of patients with renal deterioration, defined as ≥ 0.3 mg/dL increase in serum creatinine.
    - Lengh of Stay (LOS). It will be defined as hours from the index hospitalization and the discharge.
    E.5.2.1Timepoint(s) of evaluation of this end point
    - All cause of death or readmission for heart failure and or renal failure will be evaluated through Day 14 post randomization.
    - Persistent symptoms or signs of HF / no improvement will be evaluated at 6, 12, 24 and 48 hours from start of drug infusion, daily through index hospitalization and through Day 5.
    - Renal deterioration will be evaluated at 24 and 48 hours from start of drug infusion, at Day 5 and at Day 14.
    - Length of stay will be evaluated through Day 30 post randomization.
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 Yes
    E.8.2.3.1Comparator description
    Standard of Care
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA557
    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
    Austria
    Belgium
    Bulgaria
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Greece
    Hungary
    Iceland
    Italy
    Norway
    Poland
    Portugal
    Romania
    Russian Federation
    Serbia
    Slovakia
    Slovenia
    Spain
    Sweden
    Switzerland
    United Kingdom
    E.8.7Trial has a data monitoring committee Yes
    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
    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 months5
    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 months5
    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: 700
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2483
    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 Yes
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3183
    F.4.2.2In the whole clinical trial 3183
    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)
    None
    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 Decision2014-04-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-01-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-04-25
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