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    Summary
    EudraCT Number:2021-002300-12
    Sponsor's Protocol Code Number:EPOS_ZKSJ0134
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-07-12
    Trial 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 number2021-002300-12
    A.3Full title of the trial
    Epirubicin for the Treatment of Sepsis & Septic Shock
    Epirubicin für die Behandlung von Sepsis und septischen Schock
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluation of safety of low dose epirubicin in patients with Sepsis and septic shock.
    Beurteilung der Sicherheit von niedrig dosiertem Epirubicin bei Patienten mit Sepsis und septischem Schock.
    A.3.2Name or abbreviated title of the trial where available
    EPOS-1
    A.4.1Sponsor's protocol code numberEPOS_ZKSJ0134
    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 SponsorFriedrich Schiller University
    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 supportBundesministerium für Bildung und Forschung (BMBF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJena University Hospital, Center for Clinical Studies
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressSalvador Allende Platz 27
    B.5.3.2Town/ cityJena
    B.5.3.3Post code07747
    B.5.3.4CountryGermany
    B.5.5Fax number004936419399969
    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 Yes
    D.2.1.1.1Trade name Epirubicin 50 mg HEXAL® Injektionslösung
    D.2.1.1.2Name of the Marketing Authorisation holderHexal AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical 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 INNEpirubicinhydrochlorid
    D.3.9.1CAS number 56390-09-1
    D.3.9.2Current sponsor codeEpirubicin
    D.3.9.3Other descriptive nameEPIRUBICIN HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01915MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2
    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) 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 No
    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 placeboInfusion
    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
    Adult (≥ 18 years) patients admitted to the ICU or IMC with sepsis or septic shock, diagnosed within the previous 24 hours.
    Erwachsene (≥ 18 Jahre) Patienten die mit Sepsis oder septischem Schock, diagnostiziert innerhalb der letzten 24 Stunden, auf die Intensivstation (ICU)/Überwachungsstation (IMC) eingeliefert werden.
    E.1.1.1Medical condition in easily understood language
    patients with severe infection and concomitant organ dysfunction
    Patienten mit schwerer Infektion und begleitender Funktionsstörung von Organen
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10040047
    E.1.2Term Sepsis
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess safety of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock
    Bewertung der Sicherheit von niedrig dosiertem Epirubicin als Zusatztherapie bei Patienten mit Sepsis und septischen Schock.
    E.2.2Secondary objectives of the trial
    To assess efficacy of low-dose epirubicin as an adjunctive therapy for patients with sepsis and septic shock
    Bewertung der Wirksamkeit von niedrig dosiertem Epirubicin als Zusatztherapie bei Patienten mit Sepsis und septischen Schock.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients (≥ 18 years) admitted to the ICU/IMC with sepsis or septic shock, diagnosed within the previous 24 hours.
    Written informed consent of subject or its authorized representative or legal representative or confirmation of the urgency of participation in the clinical trial and the possible benefit to the subject by an independent consultant or the implementation of other established procedures according to the local regulations of the contributing center to include subjects who are unable to provide informed consent.
    Erwachsene (≥ 18 Jahre) Patienten die mit Sepsis oder septischem Schock, diagnostiziert innerhalb der letzten 24 Stunden, auf die Intensivstation/Überwachungsstation eingeliefert werden.
    Schriftliche Einwilligung des Probanden oder des bevollmächtigten Vertreters oder des gesetzlichen Vertreters oder eine Bestätigung der Dringlichkeit für die Teilnahme an der Klinischen Prüfung und des möglichen Nutzens für den Probanden, durch einen unabhängigen Berater oder die Durchführung anderer etablierter Verfahren gemäß den lokalen Vorschriften des beteiligten Prüfzentrums, um Probanden einzuschließen, die nicht in der Lage sind ihre Einwilligung selbst zu geben.
    E.4Principal exclusion criteria
    • Leukopenia/Neutropenia/Thrombocytopenia-prior or upon inclusion (Leukocyte Count <4000/L; Neutrophil/ platelets Count below Lower Limit of Normal).
    • Weight >135 kg/BMI >45.
    • Active neoplasia.
    • History of chemotherapy.
    • Hypersensitivity to epirubicin
    • History of bone marrow or solid organ transplantation.
    • Immunosuppressive therapy.
    • Acute severe infection within 4 weeks prior to admission (Hospitalization or admission to higher level clinical care facility for infection).
    • Chronic infection.
    • Cardiomyopathy with a documented ejection fraction <30% or ICD implantation.
    • Acute liver failure following the European Association for the Study of the Liver definition as International Normalized Ratio (INR) >1.5 and elevation of transaminases > 3 times of the upper normal limit (2).
    • Pregnancy during all trimesters/breast-feeding.
    • Chronic mechanical ventilation dependency.
    • Cystic fibrosis.
    • Concomitant medication with Verapamil or Cimetidine.
    • Prior enrollment in this study.
    • Participation in another clinical intervention trial.
    • Leukopenie/Neutropenie/Thrombozytopenie- vor oder nach Einschluss (Leukozytenzahl <4000/µL; Neutrophilen-/ Thrombozytenzahl unter der Normagrenze (Lower Limit of Normal).
    • Gewicht >135 kg/BMI >45.
    • Aktive Neoplasie.
    • Vorangegangene Chemotherapie.
    • Überempflindlichkeit gegen Epirubicin
    • Vorangegangene Knochenmark- oder Organtransplantationen.
    • Immunsuppressive Therapie.
    • Akute schwere Infektion innerhalb der letzten 4 Wochen vor Aufnahme (Hospitalisierung oder Aufnahme in eine höhere klinische Versorgungseinrichtung aufgrund einer Infektion).
    • Chronische Infektion.
    • Kardiomyopathie mit einer dokumentierten Auswurffraktion <30% oder Schrittmacherimplantation.
    • Akutes Leberversagen gemäß der “European Association for the Study of the Liver” definiert als International Normalized Ratio (INR) >1.5 und Erhöhung der Transaminasen um > 3 fache des oberen Normwertes (2).
    • Schwangerschaft während aller Trimester / Stillen.
    • Chronische Abhängigkeit von mechanischer Beatmung. • Mukoviszidose. • Begleitmedikation mit Verapamil oder Cimetidin. • Vorherige Teilnahme an dieser Studie. • Teilnahme an einer anderen klinischen Interventionsstudie.
    E.5 End points
    E.5.1Primary end point(s)
    Safety as assessed by myelotoxicity until day 14.
    Bewertung der Sicherheit anhand der Myelotoxizität bis Tag 14
    E.5.1.1Timepoint(s) of evaluation of this end point
    continuously, especially at day 0 (15, 60, 120 minutes and 3, 6, 12, 24 Hours after drug Administration), day 1, day 2, day 3, day 5, day 7, day 10, day 12 and day 14.
    kontinuierlich, insbesondere an Tag 0 (15, 60, 120 Minuten und 3, 6, 12, 24 Stunden nach Prüfpräparatgabe), Tag 1, Tag 2, Tag 3, Tag 5, Tag 7, Tag 10, Tag 12 und Tag 14.
    E.5.2Secondary end point(s)
    Degree of organ dysfunction measured by SOFA Score.
    Occurrence of Adverse events.
    Occurrence of Cardiotoxicity.
    Survival at day 14, 28 and 90.
    SOFA “Success” rate defined as a decrease of procalcitonin (PCT) serum concentration by 80% or more of its intra-individual peak value or to 0.5 μg/L or lower within 72 hours after randomization
    Grad der Organfunktionsstörung gemessen am SOFA-Score.
    Auftreten von unerwünschten Ereignissen.
    Auftreten von Kardiotoxizität.
    Überleben am Tag 14, 28 und 90.
    SOFA “Erfolgsrate” definiert als eine Abnahme von Procalcitonin (PCT)-Serumkonzentration um 80% oder mehr ihres intraindividuellen Spitzenwertes oder von 0.5 μg/L oder weniger innerhalb von 72 Stunden nach Randomisierung.
    E.5.2.1Timepoint(s) of evaluation of this end point
    continuously, especially at day 0 (15, 60, 120 minutes and 3, 6, 12, 24 Hours after drug Administration), day 1, day 2, day 3, day 5, day 7, day 10, day 12, day 14, day 28 and day 90.
    kontinuierlich, insbesondere an Tag 0 (15, 60, 120 Minuten und 3, 6, 12, 24 Stunden nach Prüfpräparatgabe), Tag 1, Tag 2, Tag 3, Tag 5, Tag 7, Tag 10, Tag 12, Tag 14, Tag 28 und Tag 90.
    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 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 No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Dosis eskaliert
    dose escalated
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    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 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 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
    The end of the study is after the last patient that has passed the 14-day safety endpoint in phase-3 has reached the 90-day endpoint or with the death of the last patient between day 14 and day 90 (LPLV).
    Das Ende der Studie ist, wenn der letzte Patient, der den 14-tägigen Sicherheitsendpunkt in Phase-3 überschritten hat, den 90-Tage-Endpunkt erreicht hat oder mit dem Tod des letzten Patienten zwischen Tag 14 und Tag 90 (LPLV).
    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 months
    E.8.9.1In the Member State concerned days
    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: 10
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 No
    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
    In this case, the trial Centers should adopt the locally established procedure for including these patients according to the local ethic Committee.
    In diesem Fall sollten die Studienzentren das lokal etablierte Verfahren zur Aufnahme dieser Patienten gemäß der lokalen Ethikkommission anwenden.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    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
    Keine
    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 Decision2021-11-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-20
    P. End of Trial
    P.End of Trial StatusOngoing
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