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    Summary
    EudraCT Number:2012-001670-28
    Sponsor's Protocol Code Number:BER-1272-0058-I
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2012-08-14
    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 - PEI
    A.2EudraCT number2012-001670-28
    A.3Full title of the trial
    Angiotensin Converting Enzyme Inhibitor (ACE) Induced Angioedema
    BERINERT
    Randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Angiotensin Converting Enzyme Inhibitor (ACE) Induced Angioedema
    BERINERT
    Randomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced Angioedema
    A.3.2Name or abbreviated title of the trial where available
    BERINERT
    A.4.1Sponsor's protocol code numberBER-1272-0058-I
    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 SponsorMedizinische Fakultät der Technischen Universität München
    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 supportCSL Behring
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMuenchner Studienzentrum
    B.5.2Functional name of contact pointBeate Schossow
    B.5.3 Address:
    B.5.3.1Street AddressIsmaningerstr. 22
    B.5.3.2Town/ cityMuenchen
    B.5.3.3Post code81675
    B.5.3.4CountryGermany
    B.5.4Telephone number0049(0)8941405840
    B.5.5Fax number0049(0)8941406322
    B.5.6E-mailbeate.schossow@mri.tum.de
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Information not present in EudraCT
    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 namePrednisolon-21-hydrogensuccinat
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolon-21-hydrogensuccinat
    D.3.9.1CAS number 2920-86-7
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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.IMP: 2
    D.1.2 and D.1.3IMP Role
    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 Information not present in EudraCT
    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 nameClemastinfumarat
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNClemastinfumarat
    D.3.9.1CAS number 14976-57-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2,68
    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.IMP: 3
    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 Berinert
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring
    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 Yes
    D.2.5.1Orphan drug designation numberORPHA 131041
    D.3 Description of the IMP
    D.3.1Product nameBerinert
    D.3.4Pharmaceutical form Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNC1-Esterase-Inhibitor
    D.3.9.1CAS number 80295-38-1
    D.3.9.3Other descriptive nameBerinert
    D.3.10 Strength
    D.3.10.1Concentration unit IU/kg international unit(s)/kilogram
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for infusion
    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
    Angiotensin – Converting – Enzyme – Inhibitors (ACEi) are used in the treatment of several types of cardiovascular and renal diseases. A known side effect of ACEi are angioedema of the head and neck region. These can lead to severe dyspnoea and the need for intubation and are thought to be bradykinin mediated. Up until now there is no study-evaluated conservative therapeutic concept for the treatment of these patients.
    Das primäre Ziel ist die Prüfung der Wirksamkeit des verabreichten C1-Esterase-Inhibitor im Vergleich zur bisherigen Standardbehandlung bestehend aus einer intravenösen Applikation von 500 mg Soludecortin H (Wirkstoff: Prednisolon-21-hydrogensuccinat, Natriumsalz) und 2 mg Tavegil (Wirkstoff: Clemastinhydrogenfumarat) bei ACE-Hemmer induzierten Angioödemen der oberen Atemschluckstraße.
    E.1.1.1Medical condition in easily understood language
    Patient with induced ACEi Angioedem.
    Patienten mit einem ACEi induziertem Angioödem.
    E.1.1.2Therapeutic area Diseases [C] - Respiratory Tract Diseases [C08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level HLT
    E.1.2Classification code 10002425
    E.1.2Term Angioedemas
    E.1.2System Organ Class 100000004870
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary Objective:
    To show that Berinert shortens the time to complete resolution of signs and symptoms of acute ACE-induced angioedema of the upper airway tract compared to placebo when given on top standard treatment
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    To compare the time to onset of relief as defined by a at least one point reduction of severity scale of ACE-induced angioedma with Berinert vs placebo

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Written informed consent to participate in the study and ability to fulfil all study requirements
     Male or female patients aged 18 years
     Patients with ACE induced angioedema (grade II-III in at least one severity scale) with imminent airway obstruction admitted to an Emergency department
     Patient is being treated with ACEi
     Patient must have acute angioedema attack caused by ACEi
     Treatment should be administered within 10 hours after onset of the angioedema
     Patients with angioedema of the head and/or neck (face, lips, cheeks, tongue, soft palate/uvula, pharynx and larynx)
     Male participants and female participants who are not capable of bearing children or who use a method of contraception that is medically approved by the health authority of the respective country
    E.4Principal exclusion criteria
     Diagnosis of angioedema of other genesis: e.g. hereditary angioedema, C1-inhibitor deficiency, allergic oedema, anaphylaxis, insect bite, trauma, abscess, local inflammation,
     local tumour, post-operative or post-radiogenic oedema, salivary gland disorders
     Participation in a clinical study in the past 30 days
     Patients with simultaneous itchiness of skin (acute urticaria)
     Patients with a history of angioedema before taking ACEI
     History of hypersensitivity to any of the study drugs or medicine with a similar chemical structure.
     Pregnancy and/or breastfeeding
     Mental retardation of the patient with restriction of general judgment and awareness
     History of drug abuse (including alcohol and alcoholic liver disorders)
     Potentially unreliable patients
     Patients who are not suitable for the study in the opinion of the investigator
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoint:
    The primary endpoint is the physician-assessed time to complete resolution of signs and symptoms of the ACE-induced angioedema at lips, tongue, hyopharynx or larynx maintained at least for one hour follow-up time measurement
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary data analysis will be on all patients receiving study medication (ITT). The observed longest resolution times of the most severely affected anatomical location will be taken as the primary endpoint time measure. In an additional sensitivity analysis resolution time measures in patients who require rescue medication will be imputed with the longest resolution time interval observed in the study (worst-case imputation rule).
    E.5.2Secondary end point(s)
    Secondary endpoint:
    Time between start of study medication administration and time of onset of relief defined by at least one point reduction of oedema severity score. The severity score of the upper airway obstruction will be assessed by the treating physician using a 4 grade (I-IV) assessment scale that describes the severity at 4 anatomical locations of the upper airway tract (lips, tongue, hyopharynx, and larynx).
    Occurrence of adverse events ( serious and unserious), most notably the occurrence of any thrombotic events (e.g. myocardial infarction, venous thrombosis and others) up to 4 weeks after study drug administration.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time between start of study medication administration and time of onset of relief, defined by at least one point reduction of oedema severity scale, will be described by median, quartiles, mean, min and max for both groups. Kaplan-Meier analysis will be performed for the two treatment groups, censoring patients who did not achieve complete restitution and ones who received rescue medication.
    The between group difference will be accessed both with the Log-rank and with the Wilcoxon test.
    Occurrence of adverse events ( serious and unserious), most notably the occurrence of any thrombotic events (e.g. myocardial infarction, venous thrombosis and others) up to 4 weeks after study drug administration.
    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) 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    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 No
    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 concerned4
    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
    The trial will end after 52 Patients were included.
    It is estimated that all patients can be included within 30 month
    Die Studie wird beendet wenn 52 Patienten eingeschlossen wurden . Es ist geplant, dass innerhalb von 30 Monaten alle Patienten eingeschlossen sind.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months6
    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: 52
    F.1.3Elderly (>=65 years) No
    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 state52
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 52
    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)
    All patient with ACEi induced angioedema will be scheduled for a planned visite over a fixed period between3-6 month, independently if they were included in the study.
    Alle Patienten mit einem ACE-Hemmer induziertem Angioödem werden in den folgenden 3-6 Monaten unabhängig ob Sie an der Studie teilnehmen mindestens 1x zur Kontrolluntersuchung einbestellt.
    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 Decision2013-03-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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