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    Summary
    EudraCT Number:2007-007862-39
    Sponsor's Protocol Code Number:BE1116_3003
    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:2009-01-13
    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 number2007-007862-39
    A.3Full title of the trial
    An open-label, randomized, multicenter Phase IIIb study to assess the efficacy, safety and tolerance of BERIPLEX® P/N compared with plasma for rapid reversal of coagulopathy induced by vitamin K antagonists in subjects requiring an urgent surgical procedure
    Отворено, рандомизирано, многоцентрово, фаза IIIB проучване за оценка на ефикасността, безопасността и поносимостта на Beriplex® P/N сравнен с плазма за бърза обратимост на коагулопатия, индуцирана от антагонисти на витамин К при участници, изискващи спешна хирургична процедура
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to assess the efficacy of Beriplex P/N compared with plasma for quick reversal of anticoagulant medicines in patients who require an urgent surgery
    Проучване за оценка на ефикасността на Beriplex P/N в сравнение с плазма, за бързо обратно повлияване, след прием на антикоагулантни лекарства при пациенти, които се нуждаят от спешна операция
    A.4.1Sponsor's protocol code numberBE1116_3003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00803101
    A.5.4Other Identifiers
    Name:IND number Number:13398
    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 SponsorCSL Behring 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 supportCSL Behring GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationWorldwide Clinical Trials
    B.5.2Functional name of contact pointPROGRAM DIRECTOR
    B.5.3 Address:
    B.5.3.1Street Address14, 13th LINE V.O.
    B.5.3.2Town/ cityST. PETERSBURG
    B.5.3.3Post code199034
    B.5.3.4CountryRussian Federation
    B.5.4Telephone number+7 81232771082221
    B.5.5Fax number+7 8123468248
    B.5.6E-mailYuri.Kabanov@wwctrials.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 Beriplex P/N 500
    D.2.1.1.2Name of the Marketing Authorisation holderCSL Behring GmbH
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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.3.4Pharmaceutical 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 INNFACTOR II
    D.3.9.1CAS number 9001267
    D.3.9.2Current sponsor codeHuman coagulation factor II
    D.3.9.3Other descriptive nameFACTOR II
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 48
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFACTOR VII
    D.3.9.1CAS number 9001256
    D.3.9.2Current sponsor codeHuman coagulation factor VII
    D.3.9.3Other descriptive nameFACTOR VII
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFACTOR IX
    D.3.9.1CAS number 8000079756
    D.3.9.2Current sponsor codeHuman coagulation factor IX
    D.3.9.3Other descriptive nameFACTOR IX
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number20 to 31
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFACTOR X
    D.3.9.1CAS number 9001290
    D.3.9.2Current sponsor codeHuman coagulation factor X
    D.3.9.3Other descriptive nameFACTOR X
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number22 to 60
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROTEIN C
    D.3.9.1CAS number 8000050513
    D.3.9.2Current sponsor codePROTEIN C
    D.3.9.3Other descriptive namePROTEIN C
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number15 to 45
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPROTEIN S
    D.3.9.2Current sponsor codePROTEIN S
    D.3.9.3Other descriptive namePROTEIN S
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number13 to 26
    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.IMP: 2
    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 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 nameBlood plasma
    D.3.2Product code Not applicable
    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 INNPLASMA
    D.3.9.1CAS number 8000041078
    D.3.9.2Current sponsor codeNot Applicable
    D.3.9.3Other descriptive nameNot Applicable
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number400 to 1500
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Perioperative prophylaxis for emergency surgery in subjects who have an acquired deficiency of vitamin K-dependent coagulation factors and proteins C and S
    Периоперативна профилактика за спешна операция при пациенти, които имат придобит дефицит на витамин К-зависимите фактори на кръвосъсирването и протеините C и S
    E.1.1.1Medical condition in easily understood language
    Patients under anticoagulant therapy requiring an urgent surgical procedure
    (Reversal of Coagulopathy)
    Пациенти на антикоагулантна терапия, нуждаещи се от спешна хирургична процедура
    (Обръщане на коагулопатия)
    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 14.1
    E.1.2Level PT
    E.1.2Classification code 10065667
    E.1.2Term Haemorrhage prophylaxis
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level LLT
    E.1.2Classification code 10009789
    E.1.2Term Coagulation factors decreased
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the hemostatic efficacy of Beriplex® P/N and plasma preventing excessive hemorrhages during emergency surgical interventions in subjects who have a deficiency of vitamin K-dependent coagulation factors II, VII, IX, X and proteins C and S acquired from oral anticoagulation.
    CO-PRIMARY OBJECTIVE:
    To compare efficacy of Beriplex® P/N and plasma in rapidly reducing pre-operative international normalized ratio (INR) values between the 2 treatment groups at 30 minutes after end of infusion.
    Да се сравни хемостазната ефикасност на Beriplex ® P/N и плазма за предотвратяване на обилни кръвоизливи по време на спешни хирургични интервенции при пациенти, които имат дефицит на витамин К-зависимите коагулационни фактори II, VII, IX, X и протеини С и S, придобит от перорална антикоагулантна терапия.
    Допълнителна основна цел:
    Да се сравни ефикасността на Beriplex ® P / N и плазма за бързо преоперативно намаляване на INR стойности между 2-те групи на лечение на 30 минути след края на инфузията.
    E.2.2Secondary objectives of the trial
    • To compare the plasma levels of coagulation factors II, VII, IX, and X, and protein C, and protein S between both treatment groups,
    • To compare the time from start of infusion until INR correction for both treatment groups,
    • To compare the total number of red blood cell (PRBC and whole blood) transfusions and the proportion of subjects receiving 1 or more transfusions between both treatment groups from the start of the urgent surgical procedure to 24 hours from the start of the urgent surgical procedure
    • Да се сравнят плазмените нива на коагулационни фактори II, VII, IX и X, както и протеин С и протеин S между двете терапевтични групи,
    • Да се сравни времето от началото на инфузията до корекцията на INR за двете терапевтични групи,
    • Да се сравни общият брой трансфузии на червените кръвни клетки (PRBC и цяла кръв) и дялът на пациентите, получаващи едно или повече кръвопреливания между двете терапевтични групи от началото на спешната хирургична процедура до 24 часа от началото на спешната хирургична процедура
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    . Male and female subjects 18 years or more,
    . Subjects currently on oral VKA therapy,
    . An urgent surgical procedure is required within 24 hours of the start of IMP,
    . Due to the nature of the procedure, withdrawal of oral VKA therapy and infusion of plasma are also indicated to reverse the VKA effect,
    . INR . 2 within 3 hours before start of IMP,
    . Informed consent has been obtained.
    . Мъже и жени на 18 години или повече,
    . Пациенти на перорална VKA терапия в момента,
    . Необходимост от спешна хирургична процедура в рамките на 24 часа от началото на инфузията,
    . Поради естеството на процедурата, е необходимо спиране на пероралната VKA терапия и инфузия на плазма за обръщане ефекта на VKA,
    . INR 2 в рамките на 3 часа преди началото на инфузията,
    . Подписано информирано съгласие.
    E.4Principal exclusion criteria
    • Subjects requiring urgent surgical procedures where according to the surgeon's clinical judgment, an accurate estimate of blood loss is not possible (e.g., ruptured aneurysm)
    • Subjects in whom lowering INR within normal range may present an unacceptable risk for a thromboembolic complication where the INR goal is to lower but not normalize the INR because of risk of a procedure-associated stroke
    • Acute trauma for which reversal of vitamin K antagonists alone would not be expected to control or resolve an acute bleeding complication and/or control the acute bleeding event
    • History of thromboembolic event, myocardial infarction, unstable angina pectoris, critical aortic stenosis, cerebral vascular accident, transient ischemic attack, severe peripheral vascular disease, disseminated intravascular coagulation within 3 months of enrollment
    • Пациенти, нуждаещи се от спешни хирургични процедури, където според клиничната преценка на хирурга, точна оценка на очакваната кръвозагуба не е възможна (напр., разкъсанa аневризма)
    • Пациенти, при които понижаване на INR в нормални граници може да представлява неприемлив риск за тромбоемболични усложнения, където се цели да се намали INR, но не и да се нормализира, поради риск от свързан с процедурата инсулт
    • Остра травма при която, обръщането на ефекта на антагонистите на витамин К самостоятелно не може да контролира или да предотврати остро усложнение при кървене и / или да контролира остър кръвоизлив
    • История на тромбоемболични събития, миокарден инфаркт, нестабилна стенокардия, критична аортна стеноза, мозъчен съдов инцидент, транзиторни исхемични атаки, тежка периферна съдова болест, дисеминирана вътресъдова коагулация в рамките на 3 месеца преди включване в изпитването
    E.5 End points
    E.5.1Primary end point(s)
    1) Hemostatic efficacy in preventing excessive hemorrhages during emergency surgical interventions
    2) Proportion of subjects who have a rapid decrease of INR, defined as an INR value of 1.3 or less
    1) Ефикасност на хемостазата за предотвратяване на обилни кръвоизливи по време на спешни хирургични интервенции
    2) Дял от пациентите, които са имали бързо намаление на INR, намаляне до стойности на INR от 1,3 или по-малко
    E.5.1.1Timepoint(s) of evaluation of this end point
    1) Start of infusion until immediately after surgery
    2) Baseline vs. 30 minutes after end of infusion
    1) Стартиране на инфузията, до веднага след операцията
    2) Начало срещу 30 минути след края на инфузията
    E.5.2Secondary end point(s)
    • Time to INR correction (INR ≤ 1.3) from start of infusion of IMP,
    • Number of units of red blood cells (PRBCs and whole blood) from the start of surgery through 24 hours from the start of surgery,
    • Proportion of subjects receiving red blood cells (PRBCs and whole blood) from the start of surgery through 24 hours from the start of surgery,
    • Plasma levels of Factors II, VII, IX, X and Proteins C and S
    • Време за корекция на INR (INR ≤ 1,3) от началото на инфузията на ИМП,
    • Брой трансферирани единици с червените кръвни клетки (PRBCs и цяла кръв) от началото на операцията до 24 часа от началото на операцията,
    • Дял на лицата, получаващи червени кръвни клетки (PRBCs и цяла кръв) от началото на операцията до 24 часа от началото на операцията,
    • Плазмени нива на факторите II, VII, IX, X и протеини C и S
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary endpoints 1 to 3:
    Start of surgery to 24 hours after end of surgery
    Secondary endpoint 4
    Pre-infusion through 3 hours after administration
    Вторични крайни точки от 1 до 3:
    Начало на операцията до 24 часа след края на операцията
    Вторична крайна точка 4
    Преди инфузия до 3 часа след приложението
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    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 Yes
    E.8.2.3.1Comparator description
    Прясно замразена или размразена за 24-часa плазма, която е била донор тествана
    Fresh-frozen or 24-hour or thawed plasma that has been donor tested
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belarus
    Bulgaria
    Italy
    Lebanon
    Romania
    Russian Federation
    United States
    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
    The end of the study is defined as the date of the last visit (end of viral safety follow-up) of the last subject undergoing the study.
    Края на изпитването се определя като датата на последното посещение на последния пациент в изпитването (края на проследяването за вирусна безопасност).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days15
    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: 62
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 93
    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 Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 176
    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)
    Not needed
    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 Decision2009-01-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-01-16
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-02-22
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