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    Summary
    EudraCT Number:2016-004825-17
    Sponsor's Protocol Code Number:preTopic17
    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:2017-11-09
    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 number2016-004825-17
    A.3Full title of the trial
    A Proof-of-concept study to investigate the Efficacy of Telbivudine Over Placebo in patients with Parvovirus-associated Inflammatory Cardiomyopathy
    Eine Proof-of-concept-Studie, um die Wirksamkeit von Telbivudine gegen Placebo bei Patienten mit Parvovirus-induzierter entzündlicher Kardiomyopathie zu untersuchen
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Proof of concept study to investigate the effect of the antiviral medication "Telbivudine" in patients with inflammatory heart muscle disease caused by the Parvovirus
    Eine Machbarkeitsstudie über die Wirksamkeit des antiviralen Medikaments "Telbivudine" bei Patienten mit entzündlicher Herzmuskelerkrankung, die durch das Parvovirus verursacht ist
    A.3.2Name or abbreviated title of the trial where available
    preTopic
    A.4.1Sponsor's protocol code numberpreTopic17
    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 SponsorCharité Universitätsmedizin Berlin
    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 supportBMBF
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCharité Universitätsmedizin Berlin
    B.5.2Functional name of contact pointBCRT-Clinical Development Platform
    B.5.3 Address:
    B.5.3.1Street AddressAugustenburger Platz 1
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13353
    B.5.3.4CountryGermany
    B.5.6E-mailahmed.elsanhoury@charite.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 Yes
    D.2.1.1.1Trade name Sebivo
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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.3.1Product nameSebivo
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Parvovirus B19-induced inflammatory cardiomyopathy
    Parvovirus B19-induzierte inflammatorische Kardiomyopathie
    E.1.1.1Medical condition in easily understood language
    Parvovirus B19-induced inflammation of the heart muscle
    Parvovirus B19-ausgelöste Entzündung des Herzmuskels
    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
    The main trial objective is to explore the efficacy of Telbivudine as a treatment for Parvovirus-induced inflammatory cardiomyopathy. It is expected that Telbivudine improves symptoms and cardiac functions. Further molecular studies within the trial will test the mechanism of action, whether it is B19 replication inhibition or whether there exist different/other mechanisms. Based on the results of the PreTOPIC study, Telbivudine will be classified as promising or not promising for further investigations in future large scale clinical trials.
    Das primäre Studienziel ist die Erforschung der Wirksamkeit von Telbivudine zur Behandlung der Parvovirus-induzierten inflammatorischen Kardiomyopathie. Es wird erwartet, dass Telbivudine die Symptomatik und die Herzfunktion verbessert. Weitere molekulare Studien im Rahmen dieser Studie werden den Wirkmechanismus untersuchen; ob eine Parvovirus-Replikationshemmung oder, ob andere Mechanismen vorliegen. Basierend auf den Ergebnissen der klinischen Studie wird Telbivudine als vielversprechend oder nicht vielversprechend in zukünftigen großen konfirmatorischen klinischen Studien eingestuft.
    E.2.2Secondary objectives of the trial
    The secondary trial objective is to demonstrate the safety of Telbivudine as a treatment for Parvovirus-induced inflammatory cardiomyopathy. Safety is considered as a secondary objective in the trial, since Telbivudine will be investigated at the same dose and regimen used for the approved indication, which has been shown to be safe.
    Das sekundäre Studienziel ist der Nachweis der Sicherheit von Telbivudine als Behandlung für die Parvovirus-induzierte inflammatorische Kardiomyopathie. Die Sicherheit wird als sekundäres Studienziel betrachtet, da Telbivudine in der gleichen Dosierung und dem gleichen Behandlungsschema für das genehmigte Anwendungsgebiet untersucht wird, welches als sicher erwiesen wurde.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    The health economics subproject of using Telbivudine in B19-induced inflammatory cardiomyopathy treatment

    The Health-Economics (HE) subproject will generate patient-reported quality of life data and cost-effectiveness statistics to provide a holistic appraisal of using Telbivudine therapy compared to no specific treatment (placebo).

    The HE subproject shall provide evidences for the economic value of Telbivudine in B19-induced inflammatory cardiomyopathy treatment along with clinical efficacy by ascertaining to what extent additional benefits can be gained from introducing Telbivudine compared to no treatment (placebo) and at how much greater cost.

    The HE subproject will be carried out in the course of the study.
    Das gesundheitsökonomische Subprojetkt unter der Verwendung von Telbivudine in B19-induzierter inflammatorischer Kardiomyopathie. In dem Subprojekt ,,Gesundheitsökonomie" werden Daten aus der Lebensqualität der Patienten generiert und Statistiken zur Kostenwirksamkeit hinsichtlich der Verwendung der Telbivudine-Therapie im Vergleich zu Placebo beurteilt. Das Subprojekt soll Belege für den ökonomischen Nutzen von Telbivudine in der B19-induzierten inflammatorischen Kardiomyopathie darstellen, im Einklang mit der klinischen Wirksamkeit durch die Beantwortung, welche zusätzlichen Vorteile sich aus der Einführung von Telbivudine im Vergleich zu Placebo ergeben und zu welchen höheren Kosten. Das Subprojekt wird im Verlauf der Studie durchgeführt.
    E.3Principal inclusion criteria
    •Age 18–75 years
    •Men and women
    •Symptomatic heart failure in NYHA II/III stage
    •LVEF ≤ 50% (during the previous 3 months despite at least 6 weeks of heart failure treatment)
    •Active B19 (mRNA positive) in endomyocardial
    •Symptomatic heart failure therapy at stable doses for ≥ 6 weeks
    •Patients being capable of understanding the nature, importance, and scope of the clinical trial and being able to give written informed consent
    • Alter 18-75 Jahre
    • Männer und Frauen
    • Symptomatische Herzinsuffizienz im NYHA-Stadium II/III
    • LVEF ≤ 50% (während der letzten 3 Monate trotz mindestens 6
    Wochen Behandlung von Herzinsuffizienz)
    • Aktives B19 (mRNA) positiv in der endomyokardialen biopsie
    • Symptomatische Herzinsuffizienz-Therapie in stabilen Dosen seit ≥ 6
    Wochen
    • Fähigkeit, die Patienteninformation zu verstehen und einwilligen zu können
    E.4Principal exclusion criteria
    •Recent cardiac surgery in ≤ 6 weeks
    •Major adverse cardiac events (MACE) ≤ 6 weeks (e.g. ICD shock, myocardial infarction, stroke, revascularization)
    •Cardiovascular procedure or hospitalization planned in the future
    •Coronary artery disease (CAD) with need for revascularization
    •Heart failure secondary to significant uncorrected primary valvular disease
    •Co-morbidities associated with reduced life expectancy <1 year
    •Inability to participate in exercise training (e.g. COPD GOLD III-IV, claudication ≥2b, other functional or mental limitations, significant cardiac ischemia, arrhythmias)
    •Presence of persistent atrial fibrillation
    •EMB examination showing active (mRNA positive) adeno or enterovirus (Coxsackievirus B3)
    •Positive pregnancy test in female study participants
    •Patients who take any of the prohibited concomitant medications: Immunosuppressant agents (e.g.: Corticosteroids, Cyclosporine), Interferon, anti-viral agents (e.g.: Valganciclovir, Lamivudine), and long-acting nitrates (e.g.: Isosorbide di/trinitrate).
    •Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel.
    •Subjects unable to freely give their informed consent (e.g. individuals under legal guardianship).
    •Patients who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
    •Patients who are dependent on sponsor, investigator or study site
    •Kürzliche Herzchirurgie in den letzten ≥ 6 Wochen
    •Unerwünschte kardiale Ereignisse (MACE) in den letzten ≥ 6 Wochen (ICD-Schock, Herzinfarkt, Schlaganfall, Revaskulisierung)
    •Kardiovaskuläres Verfahren oder geplante Hospitalisierung in der Zukunft
    •Koronare Herzerkrankung mit Notwendigkeit einer Revaskulisierung
    •Herzinsuffizienz aufgrund signifikanter Herzklappen-Erkrankung
    •Ko-Morbiditäten mit einer reduzierten Lebenserwartung <1 Jahr
    •Unfähigkeit zur Teilnahme am Training (z. B. COPD GOLD III-IV, Klaudikation ≥2b, andere funktionelle oder mentale Einschränkungen, signifikante Herz-Ischämie, Arrhythmien)
    •Vorhandensein eines persistenten Vorhofflimmerns
    •EMB-Untersuchung mit aktiven (mRNA-positiv) Adeno - oder Enteroviren (Coxsackievirus B3)
    •Positiver Schwangerschaftstest bei weiblichen Studienteilnehmern
    •Patienten, die eine der untersagten Begleitmedikationen einnehmen: Immunsuppressiva (z. B. Ciclosporin, Kortikosteroide:), Interferon, antivirale Wirkstoffe (z.B.: Valganciclovir, Lamivudin) und lang wirkende Nitrate (z.B. Isosorbide di/trinitrate)
    •Jegliche Form von Drogenmissbrauch, psychiatrische Störung oder andere Bedingung, die nach Ermessen des Prüfarztes die Kommunikation mit dem Prüfarzt und/oder dem designierten Studienpersonal einschränken
    •Patienten, die nicht freiwillig ihre Zustimmung geben können (z. B. Personen unter gesetzlicher Vormundschaft)
    •Patienten, die aufgrund einer von der Justiz oder den Verwaltungsbehörden erteilten Anordnung einer Einrichtung verpflichtet sind.
    •Patienten, die vom Sponsor, Prüfer oder Prüfstelle abhängig sind
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is the improvement of the patient's quality of life (QoL). QoL change will be assessed via the Minnesota Living with Heart Failure Questionnaire (MLWHFQ).
    Der primäre Endpunkt ist die Verbesserung der Lebensqualität. Die Lebensqualität (QoL) wird mit Zuhilfenahme des Fragebogens Minnesota Living with Heart Failure Questionnaire (MLWHFQ) bestimmt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    MLWHFQ: At baseline visit (day zero) and after 12 weeks of treatment.
    MLWHFQ: Bei der Baseline-Visite (Tag 0) und nach 12 Wochen der Behandlung.
    E.5.2Secondary end point(s)
    •Left ventricular ejection fraction
    •Left ventricular end diastolic diameter
    •Left ventricular global longitudinal systolic strain and systolic strain rate
    •The 6-minute walk test
    •New York Heart Association classification
    •Reduction in the number of angina/chest discomfort episodes
    •Parvovirus B19 replication; mRNA/DNA loads
    •Myocardial inflammatory status (CD3+ cells)
    •Skeletal muscle inflammatory status (CD3+ cells)

    Safety endpoints:
    Registration of exercise related adverse events and laboratory changes (Blood examination including (sodium, potassium, creatinine, haemoglobin, white and red blood cell counts, thrombocytes count, Nt-proBNP, creatine kinase MM and MB, Cardiac Troponin T, AST, ALT).
    •Linksventrikuläre Ejektionsfraktion
    •Linksventrikulärer enddiastolischer Diameter
    •Linksventrikuläre GLS und systolische Verformungsgeschwindigkeit
    •6-Minuten-Gehtest
    •New York Heart Association Klassifikation
    •Verringerung der Anzahl der Episoden von Angina pectoris/Brustbeschwerden
    •Parvovirus B19-Replikation; mRNA/DNA-Lasten
    •Myokardialer inflammatorischer Status (CD3+ Zellen)
    •Musko-skelettaler inflammatorischer Status (CD3+ Zellen)

    Sicherheitsendpunkte:
    Registrierung von Übungen im Zusammenhang mit unerwünschten Ereignissen und Laborveränderungen (Blutuntersuchung beinhaltend: Natrium, Kalium-, Kreatinin-, Hämoglobin-, weiße - und rote Blutkörperchen, Thrombozytenanzahl, Nt-proBNP, Kreatinkinase MM und MB, Herz-Troponin T, AST, ALT).
    E.5.2.1Timepoint(s) of evaluation of this end point
    •LVEF: at baseline (D0±1), week 12
    •LVEDD: at baseline (D0±1) and week 12
    •6MWT: at baseline (D0±1) and week 12
    •NYHA classification: at baseline (D0±1) and at weeks 4,8, 12
    •Number of angina/chest discomfort episodes: at baseline (D0±1) and weeks 4,8, 12
    •Biopsy; B19 RNA/cDNA; CD3+ lymphocytes: at week 12
    • Skeletal muscle biopsy: at baseline (D0±1) and at week 12

    Safety endpoints (hematological and clinical laboratory analysis): Before the start of treatment (D0-X)±1) and at baseline (D0±1), week 4,8, 12
    • LVEF: Vor Behandlungsbeginn (D0-X)±1), Baseline (D0±1), Woche 12
    •6MWT: Baseline (D0±1) und Woche 12
    •NYHA Klassifikation: bei der Baseline-Visite (D0±1) und Woche 4,8, 12
    •LVEDD: Baseline (D0±1) und Woche 12
    • Biopsie; B19 RNA/cDNA; CD3+ Lymphozyten: Woche 12
    • Musko-skelettale Biopsy: bei der Baseline-Visite (D0±1) und vor der Behandlung und Woche 12

    Sicherheitsendpunkte (hämatologische und klinische Laboranalysen): Vor Behandlungsbeginn (D0-X)±1), Baseline (D0±1), Woche 4,8, 12
    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 Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    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
    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 months3
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state25
    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
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Universitätsklinikum Tübingen
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-05-31
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