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    Summary
    EudraCT Number:2017-002927-68
    Sponsor's Protocol Code Number:2002C015G
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2017-08-31
    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 ConcernedSweden - MPA
    A.2EudraCT number2017-002927-68
    A.3Full title of the trial
    A Phase 1/2A, Dose Escalation, Randomized, Placebo Controlled Study of the Safety, Feasibility, and Efficacy of Subcutaneous Plasminogen (Human) 10 for the Treatment of Chronic Tympanic Membrane Perforation
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate safety and efficacy of a new treatment in patients with tympanic membrane perforations
    A.4.1Sponsor's protocol code number2002C015G
    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 SponsorPrometic Biotherapeutics Ltd
    B.1.3.4CountryUnited Kingdom
    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 supportPrometic Biotherapeutics Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPrometic Biotherapeutic Ltd
    B.5.2Functional name of contact pointRegulatory Affairs
    B.5.3 Address:
    B.5.3.1Street AddressHorizon Park, Barton Road
    B.5.3.2Town/ cityComberton, Cambridge
    B.5.3.3Post codeCB23 7AJ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223433 800
    B.5.6E-mailo.vaughan@prometic.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 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 namePlasminogen (Human) 10
    D.3.4Pharmaceutical form Lyophilisate 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 INNNot assigned
    D.3.9.1CAS number 9001-91-6
    D.3.9.2Current sponsor codePlasminogen (Human) 10
    D.3.9.3Other descriptive namePLASMINOGEN
    D.3.9.4EV Substance CodeSUB15018MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number7 to 13
    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 Yes
    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
    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
    Tympanic Membrane Perforation
    E.1.1.1Medical condition in easily understood language
    Ruptured eardrum
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10045210
    E.1.2Term Tympanic membrane perforation
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    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 the safety and tolerability of 5 mg and 10 mg Plasminogen (Human) 10 injected subcutaneously (SC) near the tympanic membrane in adult subjects with chronic tympanic membrane perforation (TMP).
    E.2.2Secondary objectives of the trial
    • To assess the feasibility of injecting 3 doses of SC Plasminogen (Human) 10 in 1 week at 2 dose levels (5 mg and 10 mg) near the tympanic membrane in this subject population.
    • To assess the efficacy of SC Plasminogen (Human) 10 at 2 dose levels (5 mg and 10 mg) on the healing of chronic TMP.
    • To assess the effect of SC Plasminogen (Human) 10 at 2 dose levels (5 mg and 10 mg) on ear discomfort in this study population.
    • To determine whether excision of the perforation rim affects the efficacy of SC Plasminogen (Human) 10 in this subject population.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Male or female aged 18-70 years (both inclusive)
    2) Subject has signed informed consent
    3) Diagnosed with dry TMP that has been present for at least 6 months
    4) TMP occupies 15-30% (both inclusive) of the surface area of the tympanic membrane at screening; if a subject has a TMP in both ears that meets all inclusion criteria, then the TMP associated with the worst hearing will be included in the study
    5) Female subjects of childbearing potential must have a negative urine pregnancy test at screening. Female subjects of childbearing potential who are sexually active with a non sterile male partner must agree to use adequate birth control from the time of screening until 4 weeks after the last study drug administration.
    If a male subject has not been vasectomized at least 6 months before screening and partners with a woman of childbearing potential, he must be willing to use an acceptable contraceptive method from the time of screening until 4 weeks after the last study drug administration.
    E.4Principal exclusion criteria
    1) History of hypersensitivity reaction to blood products, plasma-derived products, local anesthesia, or aprotinin
    2) Treatment with exogenous plasminogen (such as fresh frozen plasma) or a fibrinolytic agent (such as recombinant tissue plasminogen activator or streptokinase) during the 2 weeks prior to screening
    3) Treatment with anti-inflammatory agents (including Non-Steroidal Anti-Inflammatory Drugs [NSAIDs]), immunosuppressive drugs (including any form of steroids or chemotherapy), growth factors, or anti-fibrinolytics (tranexamic acid, epsilon aminocaproic acid, or aprotinin) during the 2 weeks prior to screening
    4) Treatment of any infection with systemic antimicrobial agents (antibiotics, antivirals, antifungals) during the 2 weeks prior to screening
    5) Sensorineural hearing loss (SNHL) >35 dB in the affected ear, measured no more than 14 days before first dose of study drug
    6) Recurrent or chronic bacterial infection in the affected ear during the 4 weeks prior to screening
    7) Prior middle ear surgery in the affected ear (except tympanostomy)
    8) History of malignancy treated in past 3 years (except for basal or squamous cell skin cancer)
    9) Creatinine >2x the upper limit of normal (ULN); aspartate aminotransferase (AST), alanine aminotransferase (ALT), or alkaline phosphatase (ALP) >3x ULN
    10) History of diabetes
    11) History of immunodeficiency disease
    12) Other significant medical condition that the Investigator determines could interfere with compliance or study assessments (such as: recurrent or chronic infection, dementia, substance abuse, serious or unstable chronic organ disease)
    13) If female: pregnant or lactating
    14) Has participated in another investigational drug or medical device study for any medical condition during the 4 weeks prior to screening
    E.5 End points
    E.5.1Primary end point(s)
    Number, type, severity, and causality of treatment emergent adverse events (TEAEs) by treatment
    E.5.1.1Timepoint(s) of evaluation of this end point
    Visit 6 (3-month Follow-up, i.e. End-of-Study)
    E.5.2Secondary end point(s)
    • Proportion of injections that are technically feasible by treatment, defined as the ability to insert needle SC in the ear canal ≤5 mm from the tympanic annulus and deliver entire volume of IMP or placebo SC without spillage
    • Proportion of subjects with ≥50% reduction in the percentage of tympanic membrane surface area (TMSA) occupied by the TMP at 1 month compared with baseline by treatment
    • Proportion of subjects with TMP closure at 1 month compared with baseline by treatment, defined as the absence of visible perforation by otomicroscopy AND the presence of tympanic membrane movement with pneumatic pressure change in the ear canal
    • Proportion of subjects with >50% reduction in the percentage of TMSA occupied by the TMP at 3 months compared with baseline by treatment
    • Proportion of subjects with TMP closure at 3 months compared with baseline by treatment defined as the absence of visible perforation by otomicroscopy AND the presence of tympanic membrane movement with pneumatic pressure change in the ear canal
    • Change in VAS score for ear discomfort (pain or other unpleasant sensation) at 1 month compared with baseline by treatment
    • Change in VAS score for ear discomfort at 3 months compared with baseline by treatment
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoint 1: Visit 2, Visit 3, and Visit 4
    Secondary endpoints 2, 3, and 6: Visit 5 (1-month Follow-up)
    Secondary endpoints 4, 5, and 7: Visit 6 (3-month Follow-up, i.e. End-of-Study)
    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 Yes
    E.6.13.1Other scope of the trial description
    Feasibility of administered treatments
    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
    First subcutaneous administration near tympanic membrane of plasminogen
    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
    The blind will be broken after completed cohort 1 & 2 and interim analysis. Cohort 3 will be open.
    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 trial4
    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 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 subject's last visit
    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 months6
    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: 29
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 4
    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 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 state33
    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 Decision2017-10-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-08
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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