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    The EU Clinical Trials Register currently displays   39236   clinical trials with a EudraCT protocol, of which   6428   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:2004-000219-24
    Sponsor's Protocol Code Number:3082A-101342
    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:2006-06-26
    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 number2004-000219-24
    A.3Full title of the trial
    A multicenter study to describe the immunogenic epitope(s) of factor VIII in previously treated patients with congenital hemophilia A who develop de novo factor VIII inhibitors while receiving factor VIII infusion therapy
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code number3082A-101342
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorWyeth Pharmaceuticals
    B.1.3.4CountryUnited States
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    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
    Haemophilia A is an X-linked recessive clotting disorder in which the clotting factor, factor VIII (FVIII), is deficient or inactive. Patients with low levels of FVIII have an increased tendency to bleed and is characterised by recurrent haemorrhages due to trauma, surgery or spontaneous haemorrhaging when the condition is severe.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the patterns of antibodies and associated epitopes in a subset of patients with hemophilia A, who meet the protocol entry criteria, using the methodology described in the protocol.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inhibitor positive hemophilia A patients:
    1. Written informed consent or assent, as applicable.
    2. Patients with moderate or severe congenital hemophilia A (FVIII:C <5%) .
    3. Patients with at least one positive de novo* inhibitor result (> the upper limit of normal as defined by the laboratory performing the assay), attributable by the Investigator to the patient’s current FVIII product, at the time of study visit and a positive inhibitor result confirmed by the central laboratory.
    4. Patients with exposure to at least two different FVIII products during their lifetime.
    5. Patients with > 50 cumulative ED to FVIII products.
    6. Patients able to comply with a 72-hour FVIII washout period.

    *de novo inhibitor is defined as no known history of FVIII inhibitor titer.

    Comparison group (inhibitor-free patients):
    1. Written informed consent / assent, as applicable.
    2. Patients with moderate or severe congenital hemophilia A (FVIII:C < 5%).
    3. Patients with exposure to at least two different FVIII products during their lifetime.
    4. Patients with > 50 cumulative exposure days to FVIII products.
    5. Documented negative FVIII BIA at the time of the study visit (< the upper limit of normal as defined by the laboratory performing the assay).

    E.4Principal exclusion criteria
    Inhibitor positive hemophilia A patients:
    1. Patients with a negative FVIII inhibitor result (< or equal to the upper limit of normal as defined by the laboratory performing the assay) at the study visit.
    2. Patients with known history of an inhibitor (> the upper limit of normal as defined by the laboratory performing the assay) prior to their current inhibitor.
    3. Patients who have not had at least 1 FVIII BIA performed during the last 5 years prior to their visit for this study.
    4. Patients who have received FVIII immune tolerance therapy at any time.
    5. Patients, who as of the study visit, have taken only one FVIII product during their lifetime.
    6. For patients whose current inhibitor is attributable to treatment with ReFacto; treatment with ReFacto prior to their previous product. In other words patients who were previously treated with ReFacto, then switched to another product, then switched back to ReFacto.
    7. Patients with immune disorders (e.g., HIV, myeloma, lymphoma).

    Comparison group (inhibitor-free patients):
    1. Patients with a positive FVIII inhibitor result (> the upper limit of normal as defined by the laboratory performing the assay) at the time of the study visit.
    2. Patients with a prior history of FVIII inhibitor (> the upper limit of normal as defined by the laboratory performing the assay).
    3. Patients with immune disorders (e.g., HIV, myeloma, lymphoma).

    E.5 End points
    E.5.1Primary end point(s)
    The endpoint will be a descriptive presentation of epitope regions of FVIII in samples from the three patient groups, using the methodology described in the protocol.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Information not present in EudraCT
    E.6.5Efficacy Information not present in EudraCT
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Phase IV study requested by EMEA to understand inhibitor development in haemophilia patients
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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 Information not present in EudraCT
    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 study will remain open for 36 months, or until 9 patients are enrolled in each of the three groups, whichever comes first.
    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 months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    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) Yes
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-06-26. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Children.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state5
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 27
    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)
    Patient involvement is limited to a single clinic visit (unless patients need to be recalled for a repeat blood sample).
    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 Decision2006-07-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2005-06-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2007-11-08
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