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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7263   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
    National Competent Authority:Greece - EOF
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-09-04
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedGreece - EOF
    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
    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 Information not present in EudraCT
    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 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.3.11 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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 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
    Immune thrombocytopenic purpura (ITP)
    MedDRA Classification
    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
    • To describe the clinical efficacy, pharmacodynamics, and durability of efficacy response to eltrombopag when administered to previously treated subjects with ITP as measured by platelet counts.
    • To describe the effect of re-treatment on platelet counts in subjects previously treated with eltrombopag.
    • To gain information on the optimal dosing of eltrombopag in individual subjects with ITP.
    • To describe the effect of eltrombopag on reduction and/or sparing of concomitant ITP therapies, while maintaining a platelet count ≥ 50,000/L.
    • To 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 quality of life.

    Exploratory objectives are to assess the effect of administration of eltrombopag on anti-platelet antibody titers and to use proteomic analysis to identify proteins that correlate with safety and tolerability and/or predict response to eltrombopag.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1. Subject has signed and dated a written informed consent.
    2. Adults (at least 18 years) diagnosed with ITP according to the American Society for Hematology/British Committee for Standards in Haematology (ASH/BCSH) guidelines. 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 be normal or at least not show signs suggestive of any disease likely to be associated with thrombocytopenia.
    3. Prior randomization and completion of treatment and follow up periods in an ITP study of eltrombopag (e.g., TRA100773 or TRA102537/RAISE).
    4. Subjects previously enrolled in Study TRA100773 must have completed the prescribed follow-up ophthalmic assessment at 6 months without observation of an ocular event of clinical concern.
    5. Subjects previously enrolled in TRA102537/RAISE must have completed the treatment and follow-up periods as defined in that protocol.
    6. Subject experienced no eltrombopag-related SAE or other drug intolerance on prior eltrombopag study 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 evidence of new cataract formation or any thrombosis.
    8. Ophthalmic examinations performed during prior studies have not identified ocular events of clinical concern that changed from the screening visit (baseline eye assessment).
    9. Subjects must have either initially responded (platelet count > 100,000/µL) to a previous ITP therapy or have had a bone marrow biopsy consistent with ITP within 3 years to rule out myelodysplasia or other causes of thrombocytopenia.
    10. Previous therapy for ITP with immunoglobulins (IVIg and anti-D), and cyclophosphamide must have been completed at least 4 weeks prior to Day 1. Treatment with rituximab must have been completed at least 12 weeks prior to Day 1 of study treatment. Subjects who have had a splenectomy must have had the procedure performed at least 4 weeks prior to study Day 1.
    11. Subjects treated with corticosteroids must be receiving a dose that has been stable (dose change of +/- 5% is acceptable) for at least 1 month prior to Day 1 of study. Subjects treated with cyclosporin A, mycophenolate mofetil, azathioprine or danazol must be receiving a dose that has been stable (dose change of +/- 5% is acceptable) for at least 3 months prior to Day 1 of study treatment.
    12. Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT), no history of hypercoagulable state.
    13. A complete blood count (CBC), within the reference range (including differential not indicative of a disorder other than ITP), with the following exceptions:
    • 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 (i.e., excessive blood loss).
    • ANC greater than 1500/microL (1.5 x 109/L) is required for inclusion (elevated WBC/ANC due to steroid treatment is acceptable).
    14. The following clinical chemistries must be within the normal reference range: creatinine, ALT, AST, total bilirubin, total albumin and alkaline phosphatase.
    15. Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be of non-childbearing potential (hysterectomy, bilateral oopherectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the following acceptable methods of contraception 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 female;
    • Systemic contraceptives (combined or progesterone only).
    16. Subject is able to understand and comply with protocol requirements and instructions.
    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 diagnosis.
    2. History of malignancy. NOTE: Patients with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma, are eligible.
    3. History of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism).
    4. Any prior history of arterial or venous thrombosis AND at least two of the following risk factors: Factor V Leiden, hormone replacement therapy, systemic contraception (containing estrogen), smoking, diabetes, hypercholesterolemia, medication for hypertension or cancer.
    5. Pre-existing cardiac disease (including congestive heart failure, and arrhythmia requiring treatment), or clinically significant findings on resting 12-lead ECG at screening.
    6. Female subjects who are nursing or pregnant (positive serum or urine beta-human chorionic gonadotrophin (beta-hCG) pregnancy test) at screening or pre-dose on Day 1.
    7. History of alcohol/drug abuse.
    8. Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
    9. Subject treated with aspirin, aspirin-containing compounds, salicylates, anti-coagulants, quinine or non-steroidal anti-inflammatories (NSAIDs) for > 3 consecutive days within 2 weeks of the study start and until the end of the study.
    10. Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements, within 1 week of the study start (see Section 9.1.1. for instructions for taking calcium and vitamin supplements). Subjects that have consumed rosuvastatin or pravastatin within 1 week of the first dose of study medication and/or will require these medications during the study period.
    11. History of platelet agglutination abnormality that prevents reliable measurement of platelet counts.
    12. 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.
    13. A subject is planning to have cataract surgery.
    14. In France, a subject is neither affiliated with nor a beneficiary of a social security category.
    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 Information not present in EudraCT
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 No
    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.8.6 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 Information not present in EudraCT
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    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 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 2006-09-04. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 200
    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 Decision2006-10-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-02-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-07-06
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