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    Summary
    EudraCT Number:2009-013220-24
    Sponsor's Protocol Code Number:3.0
    National Competent Authority:Czech Republic - SUKL
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-03-19
    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 ConcernedCzech Republic - SUKL
    A.2EudraCT number2009-013220-24
    A.3Full title of the trial
    Plasma Exchange and Glucocorticoid in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomised Controlled Trial.
    Výměnná plazmaferéza a dávkování kortikosteroidů v léčbě vaskulitid asociovaných s protilátkami proti cytoplazmě neutrofilních leukocytů (ANCA-asociovaných vaskulitid): mezinárodní, randomizovaná, kontrolovaná studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Plasma Exchange and Glucocorticoid in the Treatment of Anti-neutrophil Cytoplasm Antibody Associated Vasculitis: an International Randomised Controlled Trial.
    Výměnná plazmaferéza a dávkování glukokortikoidů v léčbě ANCA-asociovaných vaskulitid: multicentrická, randomizovaná, kontrolovaná studie.
    A.3.2Name or abbreviated title of the trial where available
    PEXIVAS
    A.4.1Sponsor's protocol code number3.0
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN07757494
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00987389
    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 SponsorCambridge University Hospitals NHS Trust
    B.1.3.4CountryUnited Kingdom
    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 supportMedical Research Council
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportNational Institutes of Health Research
    B.4.2CountryUnited Kingdom
    B.4.1Name of organisation providing supportFood and Drug Administration Office for Orphan Product Development
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportNational Institute of Health
    B.4.2CountryUnited States
    B.4.1Name of organisation providing supportCanadian Institutes of Health Research
    B.4.2CountryCanada
    B.4.1Name of organisation providing supportNational Health and Medical Research Council
    B.4.2CountryAustralia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVasculitis Research Office, Box 246,Addenbrooke´s Hospital
    B.5.2Functional name of contact pointBiljana Brezina
    B.5.3 Address:
    B.5.3.1Street AddressHills Road
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB2 0QQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441223256731
    B.5.5Fax number+441223586767
    B.5.6E-mailbiljana.brezina@addenbrookes.nhs.uk
    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 Yes
    D.2.1.1.1Trade name Prednison 20 Léčiva
    D.2.1.1.2Name of the Marketing Authorisation holderZentiva, k.s.
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.1CAS number 8056-11-9
    D.3.9.4EV Substance CodeAS2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20 mg
    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 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 Prednison 5 Léčiva
    D.2.1.1.2Name of the Marketing Authorisation holderZentiva, k.s.
    D.2.1.2Country which granted the Marketing AuthorisationCzech Republic
    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 Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPrednisolone
    D.3.9.1CAS number 8056-11-9
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5 mg
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ANCA associated vasculitis
    ANCA-asociovaná vaskulitida
    E.1.1.1Medical condition in easily understood language
    ANCA associated vasculitis
    vaskulitida vázaná na ANCA protilátky
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10050894
    E.1.2Term Anti-neutrophil cytoplasmic antibody positive vasculitis
    E.1.2System Organ Class 10021428 - Immune system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    There are 2 principal questions for this research:
    1) Does the addition of 7 plasma exchange procedures to usual therapy early in the treatment of patients with severe ANCA associated vasculitis significantly reduce their risk of death or kidney failure?
    2) Does a reduced-dose regimen of steroids compared to a standard-dose regimen in the first 6 months of treatment of patients with ANCA associated vasculitis significantly reduce their risk of death or kidney failure?
    E.2.2Secondary objectives of the trial
    1) Does the addition of plasma exchange or a reduced dose regimen of steroids lead to differences in disease control in patients with ANCA associated vasculitis?
    2) Does the addition of plasma exchange or a reduced dose regimen of steroids lead to a difference in adverse events in patients with ANCA associated vasculitis?
    3) Does the addition of plasma exchange or a reduced dose regimen of steroids lead to a difference in health related quality of life in patients with ANCA associated vasculitis?
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) New or previous diagnosis of ANCA associated vasculitis
    2) Positive test, at any point in the subject´s disease course, by ELISA, for proteinase 3-ANCA or myeloperoxidase - ANCA
    3) Has a severe manifestation of vasculitis as defined by either a) renal vasculitis resulting in an estimated glomerular filtration rate below 50 ml/min; or b) lung haemorrhage
    4) Provision of informed consent by patient or a surrogate decision maker
    E.4Principal exclusion criteria
    1) Presence of concomitant anti-glomerular basement membrane disease or another vasculitic disease
    2) Requirement for dialysis for >21 days in the period immediately preceeding enrollment
    3) Age <15 (In the Czech Republic age < 18)
    4) Pregnancy
    5) Inability or unwillingness to comply with birth control/abstinence
    6) Treatment for vasculitis with cyclophosphamide and/or glucocorticoids for >14 days prior to randomisation or rituximab >28 days prior to randomisation
    7) A comorbidity on condition that, in the opinion of the investigator, precludes the use of cyclophosphamide/rituximab, glucocorticoids, or plasma exchange or absolutely mandates the use of plasma exchange.
    8) Plasma Exchange in 3 months prior to randomization.
    E.5 End points
    E.5.1Primary end point(s)
    Composite of i) All-cause mortality or ii) End-stage kidney failure
    E.5.1.1Timepoint(s) of evaluation of this end point
    at all study visits until at least 12 months after randomization
    E.5.2Secondary end point(s)
    The secondary objectives will be assessed using the following outcome measures: sustained remission, all cause of mortality, end stage renal disease (ESRD), serious adverse events, serious infections, Medical Outcome Survey Short Form (SF-36), Euro QoL EQ5D Index score.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at all study visits until at least 12 months after randomization;
    SF-36 and EQ5D will be assessed at baseline and at weeks 12, 26, 52 and then every 26 weeks until study termination.
    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 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
    1) no plasma exchange 2) standard dose glucocorticoids (GCs)
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Australia
    Canada
    Czech Republic
    Denmark
    Germany
    Italy
    Mexico
    New Zealand
    Norway
    Spain
    Sweden
    Switzerland
    United Kingdom
    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 trial is planned to stop 12 months after the last patient is enrolled (common closing date).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years7
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years7
    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 Yes
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 0
    F.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    No women who are pregnant or likely to become pregnant will be included. The trial will include very few subjects who will be physically incapable of giving consent as a result of their condition being studied in trial (i.e. ANCA vasculitis).
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 700
    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 the subject has ended his/her participation in the trial then he/she will receive the expected normal treatment of their ANCA vasculitis according to the practice of their local physician.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-03-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-21
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-31
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