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    Summary
    EudraCT Number:2012-000796-16
    Sponsor's Protocol Code Number:GAMr-30
    National Competent Authority:Bulgarian Drug Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-05-22
    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 ConcernedBulgarian Drug Agency
    A.2EudraCT number2012-000796-16
    A.3Full title of the trial
    PROSPECTIVE, OPEN-LABEL, NON-CONTROLLED, MULTICENTER, PHASE III CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF OCTAGAM 10% IN PRIMARY IMMUNE THROMBOCYTOPENIA
    Проспективно, открито, неконтролирано, многоцентрово, фаза III клинично изпитване за оценка ефикасността и безопасността на Octagam 10% при Първична Имунна Тробоцитопения
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to evaluate the efficacy and safety of human immune
    globulin in patients with primary immune thrombocytopenia
    Проучване за оценка ефикасността и безопасността на човешки имуноглобулин при пациенти с Първична Имунна Тробоцитопения
    A.4.1Sponsor's protocol code numberGAMr-30
    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 SponsorOCTAPHARMA AG
    B.1.3.4CountrySwitzerland
    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 supportOctapharma AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOctapharma Pharmazeutika Produktionsgesellschaft m.b.H.
    B.5.2Functional name of contact pointClinical Research Department
    B.5.3 Address:
    B.5.3.1Street AddressOberlaaer Straße 235
    B.5.3.2Town/ cityVienna
    B.5.3.3Post code1100
    B.5.3.4CountryAustria
    B.5.4Telephone number+43 1 610321295
    B.5.5Fax number+43 1 61032 9249
    B.5.6E-mailclinical.department@octapharma.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 Octagam 10%
    D.2.1.1.2Name of the Marketing Authorisation holderOctapharma (IP) Limited
    D.2.1.2Country which granted the Marketing AuthorisationBulgaria
    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 nameOctagam 10%
    D.3.4Pharmaceutical form Solution for infusion
    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 INNHuman normal immunoglobulin
    D.3.9.1CAS number 308067-58-5
    D.3.9.2Current sponsor codeOctagam 10%
    D.3.9.3Other descriptive nameIMMUNOGLOBULIN G
    D.3.9.4EV Substance CodeSUB20618
    D.3.10 Strength
    D.3.10.1Concentration unit % percent
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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) Yes
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Immune Thrombocytopenia (ITP)
    Първична Имунна Тромбоцитопения
    E.1.1.1Medical condition in easily understood language
    immune mediated disorder characterized by increased platelet
    destruction
    имунно заболяване, характеризиращо се с повишено разрушаване на тромбоцитите
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level LLT
    E.1.2Classification code 10023095
    E.1.2Term ITP
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of Octagam 10% in correcting the platelet count (PC).
    Да се оцени ефикасността на Octagam 10% при коригиране на броя тромбоцити
    E.2.2Secondary objectives of the trial
    To evaluate the safety of Octagam 10%.
    Да се оцени безопасността на Octagam 10%
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age of >=18 and <= 65 years
    • Confirmed diagnosis of chronic primary ITP of at least 12 months duration and fulfilling the following criteria...
    • Platelet count of <30x10^9/L with or without bleeding manifestations.
    • Freely given written informed consent from patient.
    • Women of childbearing potential must have a negative result on a pregnancy test (human chorionic gonadotropine [HCG]-based assay) and need to practice contraception using a method of proven reliability for the duration of the study
    • Възраст >= 18 и ≤ 65години
    • Потвърдена диагноза за хронична първична ITP с продължителност поне 12 месеца и покрити следните критерии.....
    • Брой на тромбоцитите <30x10^9/L със или без прояви на кръвотечение.
    • Доброволно предоставено писмено информирано съгласие от пациента.
    • Жените с детероден потенциал трябва да имат отрицателен резултат от теста за бременност (изследване на базата на човешки хорионгонадотропин [ЧХГ] и трябва да използват средство за предпазване от забременяване с доказана надеждност през цялото времетраене на проучването.

    E.4Principal exclusion criteria
    • Thrombocytopenia secondary to other diseases or drug-related thrombocytopenia.
    • Administration of intravenous immunoglobulin (IVIG), anti-D or thrombopoetin receptor agonists or other platelet enhancing drugs (incl. immunosuppressive or other immunomodulatory drugs) within 3 weeks before enrolment, except for:
    a) long-term corticosteroid therapy
    b) long-term azathioprine, cyclophosphamide or attenuated androgen therapy
    • Unresponsive to previous treatment with IVIG or anti-D immunoglobulin.
    • Experimental treatment (e.g. Rituximab) within 3 months before enrolment.
    • Splenectomy in the previous 4 weeks or planned splenectomy throughout the study period.
    • Patient with Evans syndrome
    • Known or suspected human immunodeficiency virus (HIV) or hepatitis C virus (HCV) infection.
    • Live viral vaccination within the last 2 months before study entry.
    • Emergency operation.
    • Severe liver or kidney disease
    • Congestive heart failure New York Heart Association (NYHA) class III or IV.
    • Non-controlled arterial hypertension
    • History of hypersensitivity to blood or plasma derived products, or any component of the investigational product.
    • Known immunoglobulin A (IgA) deficiency and antibodies against IgA.
    • History of, or suspected alcohol or drug abuse.
    • Pregnant or nursing women.
    • Unable to consent or not capable to understand the nature, significance and implications of the clinical study, or unable or unwilling to comply with the study procedures
    • Vulnerable patients (e.g. kept in detention or institutionalised)
    • Participating in another interventional clinical study or planned participation in another trial for the duration of this study.
    • Receiving any investigational medicinal product (IMP) within 3 months before study entry.
    • Patients with risk factors for thromboembolic events in whom the risks outweigh the potential benefit of Octagam treatment.
    • Тромбоцитопения, която е вторична при други заболявания или лекарствено свързана тромбоцитопения.
    • Интравенозно прилагане на имуноглобулини (IVIG), анти-D или агонисти на тромбопоетиновия рецептор или други медикаменти за усилване на тромбоцитите (вкл. имуносупресори или други имуномодулаторни медикаменти) до 3 седмици преди включване в проучването, с изключение на:
    a) продължително лечение с кортикостероиди
    b) продължително лечение с азатиоприн, циклофосфамид или атенюирана андрогенна терапия.
    • Липса на повлияване от предшестващо лечение с IVIG или анти-D имуноглобулин.
    • Експериментално лечение (като напр. Rituximab) до 3 месеца преди включването.
    • Спленектомия през последните 4 седмици или планирана спленектомия в периода на проучването.
    • Пациенти със синдрома на Evans
    • Установена или подозирана инфекция от човешки имунодефицитен вирус (HIV) или от вируса на хепатит C (HCV).
    • Ваксинация с жива вирусна ваксина през последните 2 месеца преди включване в проучването.
    • Спешна операция.
    • Тежко чернодробно или бъбречно заболяване
    • Застойна сърдечна недостатъчност от Клас ІІІ или ІV по New York Heart Association (NYHA).
    • Неконтролирана артериална хипертония .
    • Данни за свръхчувствителност в миналото към произведени от кръв или плазма продукти или към някой от компонентите на изпитвания продукт.
    • Известен дефицит на имуноглобулин A (IgA) и антитела срещу IgA.
    • Анамнеза или подозрение за злоупотреба с алкохол или наркотици.
    • Бременни и кърмещи жени.
    • Неспособност да даде информирано съгласие или неспособност да разбере същността, значението и обхвата на клиничното проучване или неспособност или нежелание за спазване на процедурите по проучването
    • Уязвими пациенти, т.е. затворници или институционализирани
    • Участие в друго интервенционално клинично проучване или планирано участие в друго клинично проучване по време на това проучване.
    • Прием на изпитвания медицински продукт (IMP) през последните 3 месеца преди включване в проучването.
    • Пациенти с рискови фактори за тромбоемболични събития, при които рисковете превишават вероятната полза от лечението с Octagam.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy measure is the PC and the increase in platelets to – and the maintenance of – specific thresholds.
    Основната мярка за ефикасност е броят на тромбоцитите и увеличението на тромбоцитите до – и подържането на – специфични прагове.
    E.5.1.1Timepoint(s) of evaluation of this end point
    continuously, see protocol
    постоянно, вж. протокола по проучването
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    • All platelet measurements will be listed and presented in standard summary statistics for each category of response and in total.
    • Number and proportion of responders with platelets reaching normal levels
    • Maximum PC.
    • Regression of haemorrhages.
    • Relationship of any new haemorrhages to PC.
    Secondary Safety Endpoints:
    • Vital signs.
    • Physical examinations.
    • AEs.
    • Laboratory parameters
    Вторични крайни точки за оценка на ефикасност:
    • Всички измервания на тромбоцитите ще бъдат описани и представени в стандартни статистически кратки описания по отделно за всяка категория на повлияване, както и обобщени.
    • Брой и пропорция (относителен дял) на респондерите с достигане на нормално ниво на тромбоцитите
    • Максимален брой тромбоцити.
    • Регресия на кръвоизливите.
    • Връзка на всяка нова хеморагия с броя на тромбоцитите
    Вторични крайни точки за оценка на безопасност:
    • Жизнени показатели.
    • Медицински прегледи.
    • НС.
    • Лабораторни показатели.
    E.5.2.1Timepoint(s) of evaluation of this end point
    continuously, see protocol
    постоянно, вж. протокола по проучването
    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 No
    E.8.1.2Open No
    E.8.1.3Single blind No
    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 No
    E.8.2.3Other No
    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 EEA25
    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
    LVLS
    Последно посещение на последен пациент
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 30
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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 end of study participation, the patient will receive the most suitable therapy currently available for his condition.
    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 Decision2012-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-07-18
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-03-29
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