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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7264   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
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    EudraCT Number:2006-000471-14
    Sponsor's Protocol Code Number:TRA105325 UM2005/00226/05
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2007-06-03
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2006-000471-14
    A.3Full title of the trial
    EXTEND (Eltrombopag eXTENded Dosing Study): An extension study of eltrombopag olamine (SB-497115-GR) in adults, with idiopathic thrombocytopenic purpura (ITP), previously enrolled in an eltrombopag study
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberTRA105325 UM2005/00226/05
    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 SponsorGlaxoSmithKline Research and Development Limited
    B.1.3.4CountryUnited Kingdom
    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.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.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 No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEMEA/OD/031/07
    D.3 Description of the IMP
    D.3.1Product nameEltrombopag
    D.3.2Product code SB497115
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 INNEltrombopag
    D.3.9.1CAS number CASRN 496775
    D.3.9.2Current sponsor codeSB497115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEltrombopag
    D.3.9.1CAS number CASRN 496775
    D.3.9.2Current sponsor codeSB497115
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNeltrombopag
    D.3.9.1CAS number CASRN496775
    D.3.9.2Current sponsor codeSB-497115
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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) Information not present in EudraCT
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D. medicinal product typeNew Chemical Entity
    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
    Immune Thrombocytopenic Purpura (ITP)
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10021245
    E.1.2Term Idiopathic thrombocytopenic purpura
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To describe the long-term safety and tolerability of oral eltrombopag treatment of subjects with ITP with or without concomitant ITP medication.
    E.2.2Secondary objectives of the trial
    Describe the clin efficacy, PD, and durability of efficacy response to eltrombopag when administered to prev treated subjects with ITP as measured by platelet counts.
    Describe the effect of re-treatment on platelet counts in subjects prev treated with eltrombopag.
    Gain information on the optimal dosing of eltrombopag in individual subjects with ITP.
    Describe the effect of eltrombopag on reduction and/or sparing of concomitant ITP therapies, while maintaining a platelet count ≥ 50,000/L.
    Assess the impact of eltrombopag on physical and mental health status, the symptoms of fatigue and bleeding and bruising and the impact of such symptoms on health-related qol.
    Exploratory objectives are to assess effect of administration on anti-platelet antibody titers; to use proteomic analysis to identify proteins that correlate with safety and tolerability and/or predict response; the relationship between genetic variants and the PK, PD, safety and/or tolerability, or efficacy may be assessed.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject has signed and dated a written informed consent.
    2. Adults (≥18 years) diagnosed with ITP according to the American Society for
    Hematology/British Committee for Standards in Haematology (ASH/BCSH)
    guidelines [George, 1996; BCSH, 2003]. In addition, the peripheral blood smear
    should support the diagnosis of ITP with no evidence of other disease causative of
    thrombocytopenia (e.g., pseudo thrombocytopenia, myelofibrosis). The physical
    examination should not suggest any disease which may cause thrombocytopenia
    other than ITP.
    3. Prior completion of treatment and follow up periods in an ITP study of eltrombopag (e.g., TRA100773 or TRA102537/RAISE or TRA108057/REPEAT).
    4. Subjects previously enrolled in Study TRA100773 must have completed the
    prescribed follow-up ophthalmic assessment at 6 months.
    5. Subjects previously enrolled in TRA102537/RAISE or other studies that may lead
    into EXTEND (e.g., TRA108057/REPEAT) must have completed the treatment and
    follow-up periods as defined in that protocol.
    6. Subject experienced no eltrombopag-related toxicity or other drug intolerance on
    prior eltrombopag study (e.g., TRA100773 or TRA102537/RAISE or
    TRA108057/REPEAT) even if resolved; subjects discontinued from previous study
    due to toxicity will not be eligible unless they received placebo.
    7. Subject has no intercurrent medical event, including thrombosis.
    8. Subjects must have either initially responded (platelet count > 100,000/μL) to a
    previous ITP therapy or have had a bone marrow examination consistent with ITP
    within 3 years to rule out myelodysplastic syndromes or other causes of
    9. Previous therapy for ITP with immunoglobulins (IVIg and anti-D) must have been
    completed at least 1 week prior to first dose of study medication and the platelet count must show a clear downward trend after the last treatment with immunoglobulins. Previous treatment for ITP with splenectomy, rituximab and cyclophosphamide must have been completed at least 4 weeks prior to the first dose of study medication, or clearly be ineffective.
    10. Subjects treated with concomitant ITP medication (e.g. corticosteroids or
    azathioprine) must be receiving a dose that has been stable for at least 4 weeks prior to the first dose of study medication. Subjects treated with cyclosporine A, mycophenolate mofetil or danazol must be receiving a dose that has been stable for at least 3 months prior to the first dose of study medication.
    11. Prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT) must
    be within 80 to 120% of the normal range with no history of hypercoagulable state.
    12. A complete blood count (CBC), within the reference range (including WBC
    differential not indicative of a disorder other than ITP), with the following
    • Hemoglobin: Subjects with hemoglobin levels between 10.0 g/dL and the lower
    limit of normal are eligible for inclusion, if anemia is clearly attributable to ITP
    (excessive blood loss).
    • ANC ≥ 1500/μL (1.5 x 109/L) is required for inclusion (elevated WBC/ANC due
    to steroid treatment is acceptable).
    13. The following clinical chemistries MUST NOT exceed the upper limit of normal
    (ULN) reference range by more than 20%: creatinine, ALT, AST, total bilirubin, and
    alkaline phosphatase. In addition, total albumin must not be below the lower limit of
    normal (LLN) by more than 10%.
    14. Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be of nonchildbearing potential (hysterectomy, bilateral oopherectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the
    following highly effective methods of contraception (i.e., Pearl Index <1.0%) from
    two weeks prior to administration of study medication, throughout the study, and 28
    days after completion or premature discontinuation from the study:
    • Complete abstinence from intercourse;
    • Intrauterine device (IUD);
    • Two forms of barrier contraception (diaphragm plus spermicide, and for males
    condom plus spermicide);
    • Male partner is sterile prior to entry into the study and is the only partner of the
    • Systemic contraceptives (combined or progesterone only).
    15. Subject is able to understand and comply with protocol requirements and
    E.4Principal exclusion criteria
    1. Any clinically relevant abnormality, other than ITP, identified on the screening
    examination, or any other medical condition or circumstance, which in the opinion of
    the investigator makes the subject unsuitable for participation in the study or suggests another another primary diagnosis (e.g., thrombocytopenia is secondary to another disease).
    2. Concurrent malignant disease and/or history of cancer treatment with cytotoxic
    chemotherapy and/or radiotherapy.
    3. Any prior history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), AND ≥ two of the following risk factors: hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension, cancer, hereditary thrombophilic disorders (e.g., Factor V Leiden, ATIII deficiency, etc), or any other family history of arterial or venous thrombosis
    4. Pre-existing cardiovascular disease (including congestive heart failure, New York
    Heart Association [NYHA] Grade III/IV), or arrhythmia known to increase the risk of
    thromboembolic events (e.g. artrial fibrillation), or subjects with a QTc >450 msec.
    5. Female subjects who are nursing or pregnant (positive serum or urine β-human
    chorionic gonadotrophin (β-hCG) pregnancy test) at screening or pre-dose on Day 1.
    6. History of alcohol/drug abuse.
    7. Treatment with an investigational drug within 30 days or five half-lives (whichever
    is longer) preceding the first dose of study medication.
    8. Subject treated with drugs that affect platelet function (including but not limited to
    aspirin, clopidogrel and/or NSAIDs) or anti-coagulants for > 3 consecutive days
    within 2 weeks of the study start and until the end of the study.
    9. History of platelet agglutination abnormality that prevents reliable measurement of
    platelet counts.
    10. All subjects with secondary immune thrombocytopenia, including those with
    laboratory or clinical evidence of HIV infection, antiphospholipid antibody
    syndrome, chronic hepatitis B infection, hepatitis C virus infection, or any evidence
    for active hepatitis at the time of subject screening. If a potential subject has no
    clinical history that would support HIV infection or hepatitis infection, no further
    laboratory screening is necessary; however, standard medical practice would suggest
    further evaluation of patients who have risk factors for these infections.
    11. A subject is planning to have cataract surgery.
    12. In France, a subject is neither affiliated with nor a beneficiary of a social security
    E.5 End points
    E.5.1Primary end point(s)
    Safety and tolerability parameters including, clinical laboratory tests, ocular examinations, and frequency of all adverse events
    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 Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Quality of life
    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. 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 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 Yes
    E. trial design description
    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 EEA83
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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 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.1.3Elderly (>=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 Yes
    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 2007-06-03. Yes
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    See protocol
    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 Decision2006-07-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-10-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-06
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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