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    The EU Clinical Trials Register currently displays   43973   clinical trials with a EudraCT protocol, of which   7311   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-000066-37
    Sponsor's Protocol Code Number:NM-V-101
    National Competent Authority:Czechia - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-05-04
    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 ConcernedCzechia - SUKL
    A.2EudraCT number2012-000066-37
    A.3Full title of the trial
    Double-blind, randomized, placebo-controlled study on efficacy, safety and tolerability of ancrod in patients with sudden sensorineural hearing loss

    Dvojitě zaslepená, randomizovaná, placebem kontrolovaná studie účinnosti, bezpečnosti a snášenlivosti přípravku ancrod u pacientů s náhlou sensorineurální ztrátou sluchu
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy, safety, and tolerability of Ancrod in patients with sudden hearing loss
    A.3.2Name or abbreviated title of the trial where available
    n.a.
    A.4.1Sponsor's protocol code numberNM-V-101
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01621256
    A.5.4Other Identifiers
    Name:n.a.Number:n.a.
    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 SponsorNordmark Arzneimittel GmbH & Co. KG
    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 supportNordmark Arzneimittel GmbH & Co
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNordmark Arzneimittel GmbH & Co. KG
    B.5.2Functional name of contact pointClinical Development
    B.5.3 Address:
    B.5.3.1Street AddressPinnauallee 4
    B.5.3.2Town/ cityUetersen
    B.5.3.3Post code25436
    B.5.3.4CountryGermany
    B.5.4Telephone number494122712926
    B.5.5Fax number494122712740
    B.5.6E-mailkristin.forssmann@nordmark-pharma.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 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 nameAncrod (Viprinex TM)
    D.3.2Product code NM-V
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    Subcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNANCROD
    D.3.9.1CAS number 9046-56-4
    D.3.9.2Current sponsor codeVenotrombin A
    D.3.9.3Other descriptive nameAgkistrodon serine protease
    D.3.9.4EV Substance CodeSUB00525MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number70
    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 Yes
    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 placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    sudden sensorineural hearing loss (SSHL)
    E.1.1.1Medical condition in easily understood language
    hearing loss
    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 LLT
    E.1.2Classification code 10040016
    E.1.2Term Sensorineural hearing loss
    E.1.2System Organ Class 100000013775
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The aim of this study is to evaluate the efficacy of ancrod treatment on hearing ability in patients suffering from SSHL.
    The primary objective of this study is to determine the efficacy of ancrod as primary treatment of SSHL compared to placebo in patients with unilateral sudden sensorineural hearing loss as determined by audiometry.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to evaluate:
    − The relationship between biomarkers and clinical efficacy.
    − The safety and tolerability of ancrod.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria in order to be eligible for this study:
    1. Unilateral idiopathic sudden sensorineural hearing loss ≥30 dB in at least 2 consecutive frequencies in the affected ear or ≥20 dB in 3 consecutive frequencies based upon evaluation of 8 frequencies, 0.125, 0.25, 0.5, 1, 2, 4, 6, and 8 kHz, compared to the contralateral ear.
    2. Symmetric hearing prior to onset of SSHL, according to patient’s recollection.
    3. Patients with hearing loss not greater than 90dB at 0.125, 0.25, 0.5, 1, 2, 4, 6, and 8 kHz.
    4. Enrollment has to be accomplished within 7 days after SSHL onset.
    5. Male or female aged ≥18 to ≤70 years.
    6. Women of childbearing potential who are sexually active with opposite partners have to perform adequate contraception with a combination of a highly effective method of birth control and additional barrier contraception. [Highly effective method of birth control is defined as those, alone or in combination, that result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly for the entire study duration: combined (oestrogen and gestagen) oral contraceptives, hormone implants, hormone injectables, or hormone containing intrauterine device that needed to be in place for a period of at least 2 months prior to screening. Additional barrier contraception (at least the following methods are allowed: condom of the male, diaphragm with spermicide, portio cap with spermicide) has to be used for the duration of the trial, defined as from the time of screening to at least 10 days after Day 6 (Visit 4) of the double-blind treatment phase. A single barrier method is not acceptable. Women of non-childbearing potential can be included if surgically sterile (documented complete hysterectomy or bi-tubal ligations) or post-menopausal >1 year.]
    7. Men of reproductive potential must use condoms. In addition, the female partner should also be on a safe hormonal contraception (e.g. combined oral contraceptives, hormone implants, hormone injectables or hormone containing intrauterine device) or use a barrier contraception (e.g. intrauterine device, diaphragm or portio cap with spermicide), if she is of childbearing potential.
    8. Ability to understand and to follow the study protocol.
    E.4Principal exclusion criteria
    The presence of any of the following will exclude a patient from study enrolment:
    1. Pregnant or breast-feeding female.
    2. positive pregnancy test before receiving study drug
    3. Body weight >140 kg.
    4. Bilateral SSHL.
    5. Incomplete recovery after previous SSHL.
    6. Due to history of physical efforts suspected perilymph fistula or membrane rupture.
    7. Previously existing, known retrocochlear hearing loss.
    8. Any history of any ear operation or local inflammatory disease in the past one year
    9. History of blunt or penetrating ear trauma, head trauma, barotrauma, or acoustic trauma immediately preceding SSHL.
    10. History of Menière’s disease, autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops.
    11. Treatment with steroids for any reason within the preceding 30 days.
    12. History of chronic inflammatory diseases or autoimmune diseases e.g. rheumatic disease, including rheumatoid arthritis, scleroderma, lupus erythematosus, polymyalgia rheumatica, polyarteritis nodosa, temporal/giant cell arteritis, Sjögren’s syndrome, or ulcerative colitis and Crohn’s disease.
    13. History of unstable angina, coronary artery stenting or bypass grafting within three months of enrolment, transient ischemic attacks or stroke within four weeks of enrolment.
    14. Prior chemotherapy or treatment with immunosuppressant drugs (azathioprine, chlorambucil, cyclophosphamide, or other alkylating agents), cyclosporine, etanercept, infliximab, interferon or any therapy with drugs known as ototoxic (e.g. aminoglycosides, cisplatin, loop diuretics, quinine etc.) in the past 6 months.
    15. Gastrointestinal pathology: lesions liable to bleed such as active peptic ulcer disease, inflammatory bowel disease, history of gastrointestinal bleeding, or recent hemorrhage at any anatomical site requiring medical intervention.
    16. Screening plasma fibrinogen level of <180 mg/dL.
    17. Known disorder of platelet function or coagulation abnormality.
    18. Platelet count of <100,000/mm3.
    19. Severe liver disease.
    20. Hepatic failure (e.g., aspartate aminotransferase (SGOT) or alanine aminotransferase (SGPT) ≥3 × upper limit of normal [ULN])
    21. Treatment with hyperbaric oxygen within one week prior to study drug.
    22. Renal insufficiency (e.g., blood urea nitrogen or creatinine ≥2 × ULN) or patients on renal dialysis.
    23. Use of another investigational drug within 30 days prior to SSHL onset.
    24. Any other serious medical condition that might interfere with subject evaluation over the 90-day study period, based on the investigator’s judgment, e.g. planned surgical intervention or any other condition which might give doubt for non-completing the study e.g. planned holiday, distance between investigational center and place of origin.
    25. Known hypersensitivity to the drug substance or excipients.
    26. Blood or blood product infusion within one week prior to study drug.
    27. Use of any prohibited drug listed in chapter 6.4.1 and 6.4.2 of this study protocol.
    28. Immunoglobulin infusion 4 weeks prior to study drug.
    29. Planned treatment using intramuscular injections (e.g. vaccinations, vitamin B therapy)
    30. Conditions associated with an increased risk of hemorrhaging such as major surgery, history of hemorrhagic stroke, intracranial hematoma, subarachnoid hemorrhage, diabetic retinopathy, retinopathy grade 3 or worse, known hemostatic disorders.
    31. Uremia and renal colic with calculus, cerebrovascular accident, and history of neurosurgery
    32. History of malignant hypertension and/or diastolic pressure > 105 mmHg
    33. Acute pericarditis
    34. Subacute bacterial endocarditis
    35. Septicemic states with or without evidence of diffuse intravascular coagulation
    36. History of clinically relevant immediate-type allergy (type I) with respect to e.g. mildew, (house dust) mite, cockroach, hymenoptera venom, dog, cow and honeydew melon.
    37. Hearing loss of infectious or oncology origin
    E.5 End points
    E.5.1Primary end point(s)
    The primary outcome measure for this study is the change in pure tone audiogram (PTA) in the affected ear from screening until Day 8. The PTA will be calculated as the arithmetic mean of air conduction thresholds at the affected consecutive frequencies in the frequency range of 0.125 to 8 kHz. A non-affected frequency within two affected frequencies will be included.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day 8
    E.5.2Secondary end point(s)
    Secondary outcome measures will include:
    − Change in word recognition score from screening to Day 8, Day 30 and Day 90.
    − Change of audiogram in the affected ear from screening to Day 30 and Day 90.
    − Change in fibrinogen concentration from screening to Day 2 and Day 8.
    − Change in biomarkers from screening to Day 8.
    − Patient assessment of change in hearing impairment.
    − Physician assessment of change in hearing impairment.
    − Change in tinnitus severity.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day 2, 8, 30, 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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    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 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 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial 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: 5
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 115
    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)
    The post study treatment should be done by the treating physician according to basic medical services. In case of premature study-drop out a final medical examination should be done in the study centre.
    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 Decision2015-05-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-09-18
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