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    Summary
    EudraCT Number:2018-002824-17
    Sponsor's Protocol Code Number:ACCOST-HH
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2018-11-08
    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 - PEI
    A.2EudraCT number2018-002824-17
    A.3Full title of the trial
    Placebo-controlled, double-blind, randomized trial to assess the efficacy and safety of Adrecizumab in subjects with cardiogenic shock
    Eine placebokontrollierte, doppelblinde, randomisierte Studie zur Evaluation der Wirksamkeit und Sicherheit von Adrecizumab bei Patienten mit kardiogenem Schock
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Placebo-controlled, double-blind, randomized trial to assess the efficacy and safety of Adrecizumab in subjects with cardiogenic shock
    Eine placebokontrollierte, doppelblinde, randomisierte Studie zur Evaluation der Wirksamkeit und Sicherheit von Adrecizumab bei Patienten mit kardiogenem Schock
    A.4.1Sponsor's protocol code numberACCOST-HH
    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 SponsorUniversity Medical Centre Hamburg-Eppendorf
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Medical Centre Hamburg-Eppendorf
    B.4.2CountryGermany
    B.4.1Name of organisation providing supportAdrenomed AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Centre Hamburg-Eppendorf
    B.5.2Functional name of contact pointMahir Karakas
    B.5.3 Address:
    B.5.3.1Street AddressMartinistrasse 52
    B.5.3.2Town/ cityHamburg
    B.5.3.3Post code20246
    B.5.3.4CountryGermany
    B.5.4Telephone number004940741057975
    B.5.5Fax number004940741055619
    B.5.6E-mailm.karakas@uke.de
    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 nameAdrecizumab
    D.3.2Product code HAM8101
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    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) Yes
    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 placeboSolution 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
    Cardiogenic shock
    kardiogener Schock
    E.1.1.1Medical condition in easily understood language
    Dysfunction of the ventricles of the left heart
    Pumpversagen des linken Herzens
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10007625
    E.1.2Term Cardiogenic shock
    E.1.2System Organ Class 10007541 - Cardiac disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1) To assess safety and tolerability of Adrecizumab in patients with cardiogenic shock
    2) To evaluate if improvement of vascular integrity with Adrecizumab is superior to placebo in reduction of morbidity endpoints in patients with cardiogenic shock
    1) Evaluation der Sicherheit und Verträglichkeit von Adrecizumab in Patienten mit kardiogenem Schock
    2) Evaluation der Überlegenheit von Adrecizumab im Vergleich zu Placebo in Hinblick auf eine Reduktion der Morbiditäts-Endpunkte
    E.2.2Secondary objectives of the trial
    not applicable
    nicht zutreffend
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Hospitalization for Cardiogenic shock (at the discretion of the local investigator)
    Cardiogenic shock is usually defined as:
    1.1 Systolic blood pressure < 90 mmHg > 30 min or inotropes re-quired to maintain pressure > 90 mmHg during systole
    1.2 Signs of left heart insufficiency and/ or pulmonary congestion
    1.3 Signs of impaired organ perfusion with at least one of the fol-lowing:
    1.3.1 Altered mental status
    1.3.2 Cold, clammy skin
    1.3.3 Urine output <30 ml/h
    1.3.4 Serum lactate >2mmol/l
    2. Age above 18 years at time of screening
    3. Body weight below 150 kg at time of screening
    4. Females/Males who agree to comply with the applicable contraceptive requirements of the protocol
    1. Kardiogener Schock
    2. Alter über 18 Jahren
    3. Körpergewicht unter 150 kg
    4. Frauen/Männer, die zustimmen, die kontrazeptiven Vorkehrungen einzuhalten
    E.4Principal exclusion criteria
    1. Cardiogenic shock due to significant arrhythmias, which include any of the following: sustained ventricular tachycardia, bradycardia with sustained ventricular rate <35 beats per minute, or atrial fibrilla-tion/flutter with sustained ventricular response of >160 beats per mi-nute
    2. Cardiogenic shock due to left ventricular outflow obstruction, ob-structive hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <0.8 cm2 or mean gradient >50 mmHg on prior or current echocardiogram), and severe mitral stenosis
    3. Cardiogenic shock due to mechanical cause or severe bleeding
    4. Cardiogenic shock due to untreated clinically significant CAD requiring revascularization
    5. Resuscitation > 60 minutes
    6. Severe pre-existing hepatic disease unrelated to cardiogenic shock
    7. Severe pre-existing renal disease (dialysis) unrelated to cardiogenic shock etiology
    8. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past year with a life expectancy less than 6 months
    9. History of severe asthma, eczema, or atopic allergy
    1. Kardiogener Schock aufgrund einer relevanten Arrhythmie
    2. Kardiogener Schock aufgrund einer linksventrikulären Ausflusstraktobstruktion, einer hypertrophen Kardiomyopathie, oder einer schweren Aortenstenose, oder einer schweren Mitralstenose
    3. Kardiogener Schock aufgrund einer mechanischen Ursache
    4. Kardiogener Schock aufgrund einer unversorgten KHK mit unmittelbarem Revaskularisationsbedarf
    5. Wiederbelebung über 60 Minuten
    6. Schwere unabhängig vom kardiogenen Schock vorbestehende Lebererkrankung
    7. Schwere unabhängig vom kardiogenen Schock vorbestehende Nierenerkrankung (Dialyse)
    8. Krebserkrankung mit einer Lebenserwartung unter 6 Monaten (Ausnahme Basalzellkarzinom)
    9. Krankengeschichte von schwerem Asthma, schweren Ekzemen, oder atopischen Allergie
    E.5 End points
    E.5.1Primary end point(s)
    Primary safety endpoints
    • Rate of SAEs/ AEs/SUSARs in both arms (deemed to be related to IMP)
    • Mortality related to Adrecizumab
    • Interruption of infusion due to intolerability to Adrecizumab
    • New treatment-emergent adverse events (and changes in severity and frequency in these) related to Adrecizumab

    Primary efficacy endpoint:
    • Number of days through day 30 without need for cardiovascular organ support, including vasopressors, or mechanical support (VA-ECMO, Impella)
    Primärer Sicherheitsendpunkte:
    • Anzahl der SAE/ AE/ SUSARs in beiden Therapiearmen
    • Mortalität bezogen auf Adrecizumab
    • Abbruch der Gabe von Adrecizumab aufgrund Unverträglichkeit
    • Bisher unbekannte Nebenwirkungen bezogen auf Adrecizumab (und Veränderung in Schweregrad und Häufigkeit)

    Primärer Wirksamkeitsendpunkt:
    • Anzahl der Tage bis Tag 30 ohne Bedarf einer medikamentösen (z.B. Katecholamine) oder maschinellen (z.B. VA-ECMO, Impella) Kreislaufunterstützung

    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary safety endpoints: Day 90

    Primary efficacy endpoint: Day 30
    Primärer Sicherheitsendpunkte: Tag 90

    Primärer Wirksamkeitsendpunkt: Tag 30
    E.5.2Secondary end point(s)
    1. Requirement and length of mechanical ventilation
    2. All-cause death within 30 days, and end of follow-up (90 days)
    3. Cardiovascular death within 30 days, and end of follow-up (90 days)
    4. Length of stay at Intensive Care Unit/ Intermediate Care Unit/ Heart Failure Unit in hours after application of IMP up to a total of 30 days
    5. Worsening clinical condition
    6. Peak and change (fold induction) in cardio-renal biomarkers from baseline to day 3 (including bioADM, MR-proADM, troponin, CRP, PenKid, NTproBNP, Lactate, DPP3)
    7. Patient´s Global Assessment Questionnaire (PGA), Mini-Mental state exam questionnaire (MMSE) and Euroqol 5D questionnaire (EQ-5D) at discharge, day 30 and day 90
    8. 6-minute walking test at days 30 and 90
    9. Cumulative burden of arrhythmia until discharge
    10. Rehospitalisation within 30 days and 90 days
    11. Rehospitalisation for heart failure within 30 days and 90 days
    12. An expanded safety composite event including death, MI, stroke, recurrent hospitalization, acute kidney injury, and gastrointestinal disorders will be collected, analysed and reported.
    The following secondary endpoints will only be assessed if the primary efficacy endpoint is met:
    a. Diuresis and natriuresis during and after administration of study drug
    b. Time to improvement in dyspnea by Likert scale
    c. Use of loopdiuretic and vasoactive agents
    d. Health economical calculation of disease-related costs during index hospitalization
    E.5.2.1Timepoint(s) of evaluation of this end point
    1., 5., 6., 9., 12., a., b., c., d. Day 90
    2., 3., 7., 8., 10., 11. Baseline to day 30, baseline to day 90
    4. Baseline to day 30
    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 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) 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 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 No
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects could be incapable of giving consent due to cardiogenic shock.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state150
    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 Decision2019-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-04-26
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