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    Summary
    EudraCT Number:2017-003813-24
    Sponsor's Protocol Code Number:SIFU17
    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:2018-05-02
    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 number2017-003813-24
    A.3Full title of the trial
    A phase I/IIa, prospective, mono-center, randomized, open labeled, controlled study to assess the safety and efficacy of applying Iloprost locally in the fracture site to promote bone healing in patients with proximal humeral fracture
    Eine Phase I/IIa prospektive, monozentrische, randomisierte, offene, kontrollierte Studie zur Beurteilung der Wirksamkeit und Sicherheit der Anwendung von Iloprost an der Frakturstelle zur Förderung der Knochenheilung bei Patienten mit proximaler Humerusfraktur
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial investigating Iloprost as medication to improve bone healing in patients with upper arm bone fracture.
    Eine klinische Studie, welche Iloprost als Medikament für die Verbesserung der Knochenheilung bei Patienten mit Brüchen des Oberarmknochens verbessern möchte.
    A.3.2Name or abbreviated title of the trial where available
    Ilobone
    A.4.1Sponsor's protocol code numberSIFU17
    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.4.1Name of organisation providing supportBCRT
    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-mailhisham.elazaly@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 Ilomedin
    D.2.1.1.2Name of the Marketing Authorisation holderBayer Vital GmbH
    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 IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNILOPROST
    D.3.9.1CAS number 78919-13-8
    D.3.9.4EV Substance CodeSUB08136MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Proximal humeral fracture
    Proximale Humerusfraktur
    E.1.1.1Medical condition in easily understood language
    Fractures of the upper part of the upper arm
    Knochenbruch des Oberarmknochens
    E.1.1.2Therapeutic area Body processes [G] - Bones and nerves physological processes [G11]
    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 objective of this study is to establish the safety of intraoperative local insertion of Iloprost at the fracture site for bone healing of the proximal humeral fracture.
    Das Ziel dieser Studie ist, die Sicherheit und die klinische Wirksamkeit der intraoperativ lokalen Insertion von Iloprost an der Frakturstelle zur Knochenheilung der proximalen Humerusfraktur zu etablieren.
    E.2.2Secondary objectives of the trial
    Not applicable
    Unzutreffend
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adult male or female subjects between 60 to 80 years of age old at the time of screening visit;
    Scheduled PHILOS plate for proximal humeral fracture; with angle stable plate (3 holes PHILOS plate, synthes) for proximal humerus fracture type 3 or 4 according to Neer classification
    ASA Score score ≤ 2;
    Signed written informed consent;
    Single low energy fracture;
    Surgery done within the first 96 hours from injury
    Die Patienten sind berechtigt, an dieser Studie teilzunehmen, wenn sie die folgenden Einschlusskriterien erfüllen:
    • Erwachsene männliche oder weibliche Teilnehmer zwischen 60 und 80 Jahren zum Zeitpunkt des Screening-Besuchs
    • geplante Osteosynthese mit winkelstabiler Platte (3 Loch PHILOS, Synthes) bei proximaler Humerusfraktur Typ 3 oder 4 nach Neer-Klassifikation
    • ASA-Risikoklassifikation von ≤ 2
    • Schriftliche Einwilligung und Unterschrift
    • Einzelfraktur, Geringe Bruchenergie
    • Operation innerhalb der ersten 96 Stunden nach einer Verletzung
    E.4Principal exclusion criteria
    •Immunosuppression due to illness or medication
    •Subject has malignancy undergoing treatment including chemotherapy, radiotherapy or immunotherapy
    •Known allergies to Iloprost
    •Pregnant or breast-feeding women or women of childbearing potential not protected by an effective contraceptive method of birth control (defined as pearl index < 1)
    •Subject who is currently enrolled in or has not yet completed a period of at least ( a period of time equal to 5 times as the half-life time of the drug used in the previous trial) since ending other investigational device or drug trial(s).
    •Subjects who are legally detained in an official institute
    •Patients who are dependent on sponsor, investigator or study site
    •Past history of previous same side proximal humeral surgery
    •Past history of same side proximal humeral deformity
    •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
    Die Patienten sind nicht berechtigt, an dieser Studie teilzunehmen, wenn eines oder mehrere der folgenden Ausschlusskriterien erfüllt sind:
    • Immunsuppression wegen Erkrankung oder durch Medikamenteneinnahme
    • Der Patient hat einen bösartigen Tumor und ist in Behandlung (Chemotherapie, Strahlentherapie oder Immuntherapie)
    • Bekannte Allergien gegen Iloprost
    •Schwangere oder stillende Frauen oder Frauen im gebärfähigen Alter, die keine wirksame Verhütungsmethode verwenden (definiert als Pearl-Index <1)
    • Patient, der derzeit an einer Studie teilnimmt oder diese noch nicht abgeschlossen hat (eine Zeitspanne, die dem Fünffachen der Halbwertszeit des in der vorherigen Studie verwendeten Arzneimittels entspricht), seit Beendigung eines anderen Prüfpräparats oder einer anderen Arzneimittelstudie ).
    •Patienten, die aufgrund behördlicher oder gerichtlicher Anordnungen in einem öffentlichen Institut untergebracht sind
    • Patienten, die vom Sponsor, Prüfarzt oder vom Studienzentrum abhängig sind
    • Anamnese mit Operation einer proximalen Humerusfraktur oder proximaler Humerusdeformität
    • Jegliche Form von Drogenmissbrauch, psychiatrischer Störung oder sonstiger Bedingung, die nach Ermessen des Prüfarztes die Kommunikation mit dem Prüfarzt und/oder dem zugewiesenen Studienpersonal ungültig macht
    • Personen, 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 in einer Einrichtung untergebracht sind
    E.5 End points
    E.5.1Primary end point(s)
    Identification of any noxious response or toxicity that has a causal relationship to the treatment. Toxicity shall be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE).
    Der primäre Endpunkt umfasst jegliche Identifizierung einer schädlichen Reaktion oder Toxizität, die einen kausalen Zusammenhang zur Behandlung hat. Die Toxizität wird nach dem National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) eingestuft. Ein weiterer primärer Endpunkt ist der Grad der Erhaltung des Tip-Apex-Abstands der alle Schrauben im Humeruskopf.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Post-operative (before discharge),week 3, week 6, week 12, week 26 and week 52.
    Post-operativ, in Woche 3, 6, 12, 26 und 52
    E.5.2Secondary end point(s)
    •Rate of humeral head necrosis
    •Humeral head shaft angle
    •Pain assessment (VAS)
    •Quality of life (EQ-5D)
    •Constant-Murley Score (CMS)
    •Disabilities of the Arm, Shoulder and Hand score (DASH)
    •Rate der Humeruskopfnekrose
    •Winkel des Humeruskopf-Schaft-Winkel
    • Schmerzbewertung anhand der visuellen Analogskala (VAS)
    • Lebensqualität (EQ-5D)
    • Konstante-Murley-Punktzahl (CMS)
    • Behinderungen der Arm-, Schulter- und Handpartitur (DASH)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Post-operative (before discharge), week 3, week 6, week 12, week 26 and week 52.
    Post-operativ, in Woche 3, 6, 12, 26 und 52
    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 No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    New indication for an authorized small molecule
    Neue Indikation für ein autorisiertes kleines Molekül
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Standard of care treatment
    E.8.2.4Number of treatment arms in the trial3
    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.8.5The 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
    Follow up visits following the surgical operation shall take place on week 3, 6, 12 and 26. In addition to a telephone call at week 52 for for safety assessment. The phone call at week 52 is defined as end of the study.
    Follow-up-Besuche nach dem chirurgischen Eingriff erfolgen in der Woche 3, 6, 12 und 26. Zusätzlich zu einem Telefongespräch in Woche 52 zur Sicherheitsbewertung. Der Telefonanruf in Woche 52 ist als Ende der Studie definiert.
    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 months1
    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) No
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    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 No
    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 state30
    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)
    After the trial ends, all patients shall receive the regular standard of care treatment for proximal humeral fractures.
    Nach Studienende erhalten alle Patienten die reguläre Standardbehandlung für proximale Humerusfrakturen.
    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 Decision2019-11-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-04-30
    P. End of Trial
    P.End of Trial StatusOngoing
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