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    Summary
    EudraCT Number:2019-001151-40
    Sponsor's Protocol Code Number:CTU148N
    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:2019-04-24
    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 number2019-001151-40
    A.3Full title of the trial
    Phase II pilot study: To determine an effective and tolerable dose of Hylase® "Dessau" (bovine hyaluronidase) in the treatment of hyaluronic acid filler overshoots by injection into defined areas of hyaluronic acid oversprayed areas of healthy volunteers
    Phase II Pilotstudie: Ermitteln einer wirksamen und verträglichen Dosis von Hylase® „Dessau“ (bovine Hyaluronidase) in der Behandlung von durch Hyaluronsäurefiller verursachten Überspritzungen durch Injektion in definiert mit Hyaluronsäurefiller überspritzten Hautarealen gesunder Probanden
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase II Pilot Study: To determine an effective and tolerable dose of Hylase® "Dessau" (hyaluronidase from cattle) in the treatment of hyaluronic acid hypodermic overdose by injecting a defined amount of hyaluronic acid into the skin of healthy volunteers
    Phase II Pilotstudie: Ermitteln einer wirksamen und verträglichen Dosis von Hylase® „Dessau“ (Hyaluronidase auf Rinderbasis) in der Behandlung von durch Unterspritzung mit Hyaluronsäure verursachten Überspritzungen durch Injektion in definierten Menge Hyaluronsäure in die Haut gesunder Probanden
    A.4.1Sponsor's protocol code numberCTU148N
    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 SponsorRIEMSER Pharma GmbH
    B.1.3.4CountryGermany
    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 supportRiemser Pharma GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRiemser Pharma GmbH
    B.5.2Functional name of contact pointMedical Affairs
    B.5.3 Address:
    B.5.3.1Street AddressHohenzollerndamm 150-151
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14199
    B.5.3.4CountryGermany
    B.5.4Telephone number+4930338427100
    B.5.5Fax number+493089748045
    B.5.6E-mailinfo@riemser.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 Yes
    D.2.1.1.1Trade name Hylase "Dessau" 150 I.E.
    D.2.1.1.2Name of the Marketing Authorisation holderRiemser Pharma 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.3.1Product nameHylase "Dessau" 150 I.E.
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHyaluronidase
    D.3.9.3Other descriptive nameHYALURONIDASE
    D.3.9.4EV Substance CodeSUB02552MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.3Concentration number150
    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 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 placeboSolution for injection/skin-prick test
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    In this study, healthy subjects get an artificial over-injection with Hyaluron acid filler on the back of the hands.
    To demonstrate the effectiveness of hylase® "Dessau" as an antidote for hyaluronic acid filler, the injected fillers are subsequently treated with a defined amount of hylase® "Dessau" .
    Im Rahmen dieser Studie bekommen gesunde Probanden eine künstliche Überspritzung mit Hyaluronsäurefillern auf den Handrücken.
    Zum Nachweis der Wirksamkeit von Hylase® "Dessau" als Antidot für Hyaluronsäurefiller werden die injizierten Filler anschließend mit einer definierten Menge Hylase "Dessau" behandelt.
    E.1.1.1Medical condition in easily understood language
    Healthy people are injected with a specified amount of hyaluronic acid under the skin, which is then to be dissolved again with hylase® "Dessau".
    Gesunde Menschen wird eine festgelegte Menge Hyaluronsäure unter die Haut gespritzt, welche anschließend mit Hylase® "Dessau" wieder aufgelöst werden soll.
    E.1.1.2Therapeutic area Not possible to specify
    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
    Determination of a tolerated and effective dose of Hylase® "Dessau" (bovine hyaluronidase) as an antidote for the treatment of overcorrections (Blue Lines, Persistent
    Swelling, vascular involvement) by Hyaluronsäurefiller based on the treatment artificially caused overspray on the hands.
    Bestimmung einer verträglichen und wirksamen Dosis von Hylase® "Dessau" (bovine Hyaluronidase) als Antidot zur Behandlung von Überkorrekturen (Blue Lines, persistierende Schwellungen, Gefäßbeteiligung) durch Hyaluronsäurefiller anhand der Behandlung künstlich hervorgerufener Überspritzungen an den Händen.
    E.2.2Secondary objectives of the trial
    - Assessment of the safety and tolerability of Hylase® "Dessau" in clinical use with hyaluronic acid filler
    • Detection of possible occurrence of known adverse events after treatment with Hylase® "Dessau" (bovine hyaluronidase) (according to Fachinfo Stand 11/2018)
    • Detection of any new, as yet unknown adverse events after treatment with Hylase® "Dessau"
    • Beurteilung der Sicherheit und Verträglichkeit von Hylase® „Dessau“ in der klinischen Anwendung bei Hyaluronsäurefillern
    • Detektion von eventuell auftretenden bekannten unerwünschten Ereignissen nach Behandlung mit Hylase® „Dessau“ (bovine Hyaluronidase) (entsprechend Fachinfo Stand 11/2018)
    • Detektion von eventuell neuen, noch nicht bekannten unerwünschten Ereignissen nach Behandlung mit Hylase® „Dessau“
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female and male subjects aged ≥ 18 years and ≤65 years
    • Written consent of study participants and ability to understand and follow the study and instructions
    • Healthy subjects in good physical condition
    • Heart rate >50 bis <90 beats/Minute and blood pressure of systolic >90 to <140 and diastolic >50 to <90 mmHg
    • Weibliche und männliche Probanden im Alter von ≥ 18 Jahre bis ≤65 Jahre
    • Schriftliches Einverständnis der Studienteilnehmer und Fähigkeit, die Studie sowie Instruktionen zu verstehen und zu befolgen
    • Gesunde Probanden in guter körperlicher Verfassung
    • Herzfrequenz von >50 bis <90 Schläge/ pro Minute und Blutdruck systolisch >90 bis <140, diastolisch von >50 bis <90 mmHg
    E.4Principal exclusion criteria
    1. Known hypersensitivity to hyaluronidase, bovine proteins and / or gelatin
    2. Pregnancy or breastfeeding throughout the study period
    3. Women of childbearing potential who do not use contraceptive methods with a Pearl Index ≤ 1, eg. Eg pill, implant, depot injection, sterilization (exception: menopause since ≥1 year)
    4. Subjects with congenital heart disease, venous congestion or shock symptoms
    5. Subjects with infections or infected treatment area
    6. Known insect poison allergy
    7. Subjects with infections, wounds and skin diseases and / or caused by stitches or bites swelling in the treatment area
    8. Existing alcohol and / or drug addiction
    9. Subjects simultaneously taking medicines containing antihistamines, heparin, morphine, chondroitin sulfate B, cholic acid, dicumarol, vitamin C, flavonoids, sulphonate detergents, salicylic acid derivatives and heavy metal ions (Fe, Mn, Cu, Zn, Hg), salicylic acid derivatives, histamine, calcium or phosphates. These substances can inhibit or enhance the action of the hylase.
    10. Subjects with Cancer and Autoimmune Diseases (e.g., psoriasis)
    11. Subjects with known immune deficiency
    12. Tendency to keloid formation and / or hypertrophic scarring
    13. Participation in another study within the last 30 days
    14. Subjects who are unwilling or unable to follow the requirements of the protocol
    15. Employees / Relatives of the Sponsor or Employees / Relatives of the Head of the Clinical Trial (LKP)
    1. Bekannte Überempfindlichkeit gegen Hyaluronidase, Rinderproteine und/oder Gelatine
    2. Schwangerschaft oder Stillzeit während der gesamten Studiendauer
    3. Gebärfähige Frauen, die keine Verhütungsmethoden mit einem Pearl-Index ≤ 1 verwenden, z. B. „Pille“, Implantat, Depotinjektion, Sterilisation (Ausnahme: Menopause seit ≥1 Jahr)
    4. Probanden mit angeborenem Herzfehler, venösem Stau oder Schocksymptomen
    5. Probanden mit Infektionen oder infiziertem Behandlungsareal
    6. Bekannte Insektengiftallergie
    7. Probanden mit Infektionen, Wunden und Hauterkrankungen und / oder durch Stiche oder Bisse verursachte Schwellungen in dem Behandlungsareal
    8. Bestehende Alkohol- und/oder Drogenabhängigkeit
    9. Probanden, die gleichzeitig Arzneimittel einnehmen, die Antihistaminika, Heparin, Morphin, Chondroitinsulfat B, Cholsäure, Dicumarol, Vitamin C, Flavonoide, Sulfonatdetergenzien, Salicylsäurederivate und Schwermetallionen (Fe, Mn, Cu, Zn, Hg), Salicylsäurederivate, Histamin, Calcium oder Phosphate enthalten. Diese Substanzen können die Wirkung der Hylase inhibieren oder verstärken.
    10. Probanden mit Krebs- und Autoimmunerkrankungen (z.B. Schuppenflechte)
    11. Probanden/innen mit bekanntem Immundefekt
    12. Neigung zu Keloidbildungen und/oder hypertrophe Narbenbildung
    13. Teilnahme an einer anderen Studie innerhalb der letzten 30 Tage
    14. Probanden, die nicht bereit oder nicht in der Lage sind, den Anforderungen des Prüfplans zu folgen
    15. Angestellte/Verwandte des Sponsors oder Angestellte/Verwandte des Leiters der klinischen Prüfung (LKP)
    E.5 End points
    E.5.1Primary end point(s)
    Determination of the dose of hylase at 1 and 2 day (s) after treatment with a
    Hyaluronic acid filler a response after 24 h, complete volume reduction by palpation,
    and ultrasound.
    A response is clearly defined by a palpation value of 0 or 1, one with
    ultrasound demonstrated full volume reduction of more than 90%,
    determined by the blinded investigator.
    Bestimmung der Hylase-Dosis, bei der nach 1 bzw. 2 Tag(en) nach Behandlung mit einem Hyaluronsäurefiller eine Response nach 24 h, vollständige Volumenreduktion durch Palpation, und Ultraschall, festzustellen ist.
    Eine Response ist hierbei eindeutig definiert durch einen Palpationswert von 0 oder 1, eine mit Ultraschall nachgewiesene vollständige Volumenreduktion von mehr als 90%, bestimmt durch den verblindeten Prüfarzt.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 1 or 2 after HA filler application.
    Tag 1 oder Tag 2 nach HA-Filler Gabe.
    E.5.2Secondary end point(s)
    Assessment of the safety and tolerability of Hylase® "Dessau" in clinical use as an antidote for hyaluronic acid filler
    - Number of adverse events per dose and HA filler
    - Number of expected side effects per dose and HA filler
    - Number of unexpected side effects per dose and HA filler
    Detection of adverse events and side effects after treatment with
    HA fillers
    Assessment of volume reduction with 3D camera
    Beurteilung der Sicherheit und Verträglichkeit von Hylase® "Dessau" in der klinischen Anwendung als Antidot für Hyaluronsäurefiller
    - Anzahl von unerwünschten Ereignissen pro Dosis und HA-Filler
    - Anzahl von erwarteten Nebenwirkungen pro Dosis und HA-Filler
    - Anzahl von unerwarteten Nebenwirkungen pro Dosis und HA-Filler
    Detektion von unerwünschten Ereignissen und Nebenwirkungen nach Behandlung mit
    HA-Fillern
    Beurteilung der Volumenreduktion mittels 3D-Kamera
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 1, 2, 7 or 8, and 14.
    Tag 1, 2, 7 oder 8 und Tag 14.
    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 Yes
    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 Yes
    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 Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned2
    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 No
    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
    Last patient last visit
    Letzter Patient bei letzter Visite
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 19
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 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 state57
    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 Decision2019-07-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-05-16
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-03-31
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