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    Summary
    EudraCT Number:2004-000367-98
    Sponsor's Protocol Code Number:TRA100773
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-02-23
    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 ConcernedDenmark - DHMA
    A.2EudraCT number2004-000367-98
    A.3Full title of the trial
    A double-blind, randomised, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of SB-497115-GR, a thrombopoietin receptor agonist, administered at 30, 50 and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenic purpura.
    A.4.1Sponsor's protocol code numberTRA100773
    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.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.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.3.8 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 number75
    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 number100
    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.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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    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 determine the efficacy of SB-497115-GR as a thrombopoietic agent, when administered once daily for 6 weeks to previously treated adult subjects with chronic ITP.
    E.2.2Secondary objectives of the trial
    •To assess the safety and tolerability of SB-497115-GR when administered once daily for 6 weeks to previously treated adult subjects with chronic ITP.
    •To characterize the population pharmacokinetic profile of oral SB-497115-GR using a combined sparse and serial pharmacokinetic sampling strategy when administered once daily for 6 weeks to previously treated adult subjects with chronic ITP.
    •To determine the pharmacodynamic effect of SB-497115-GR on markers of thrombopoiesis when administered once daily for 6 weeks to previously treated adult subjects with chronic ITP.
    •To assess the impact of SB-497115-GR on the incidence and severity of symptoms of thrombocytopenia when administered once daily for 6 weeks to previously treated adult subjects with chronic ITP.
    •To assess the impact of SB-497115-GR on the quality of life when administered once daily for 6 weeks to previously treated adult subjects with chronic ITP.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Diagnosed with chronic ITP for at least 6 months prior to screening, and have a platelet count of < 30,000 platelets/L on Day 1 (or within 24 hours prior to dosing on Day 1).
    2.Previously treated patients who have either not responded to one or more prior therapies, or who have relapsed within 3 months of prior therapy. Previous treatments for chronic ITP include corticosteroids, immunoglobulins (IVIG and anti-D immunoglobulin), azathioprine, danazol, cyclophosphamide, immunomodulators and/or splenectomy. Previous therapy for ITP with immunoglobulins, immunomodulators and cyclophosphamide must have been completed at least 2 weeks prior to randomization (See Inclusion Criterion 3).
    3.Subjects treated with maintenance immunosuppressive therapy (corticosteroids, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must be receiving a dose that has been stable for at least 1 month.
    4.Normal prothrombin time (PT/INR) and activated partial thromboplastin time (aPTT), no history of clotting disorder, other than ITP.
    5.A complete blood count (CBC), reticulocyte count, creatinine, ALT, AST, bilirubin and/or alkaline phosphatase within the reference range, with the following exceptions:
    •platelet count < 30,000/L is required for inclusion,
    •Hemoglobin: females and males  10.0 g/dL are eligible for inclusion,
    •ANC  1500/L (1.5 x 109/L) is required for inclusion (elevated WBC/ANC due to steroid treatment is acceptable).
    6.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).
    7.Subject is  18 years old.
    8.Subject has signed and dated written informed consent.
    9.Subject is able to understand and comply with protocol requirements and instructions and intends to complete the study as planned.
    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.
    2.History of thrombosis within the last year.
    3.Pre-existing cardiac disease (including congestive heart failure, and arrhythmia requiring treatment); myocardial infarction in the last 3 months; or clinically significant findings on resting 12-lead ECG at screening.
    4.Female subjects who are nursing or pregnant (positive serum or urine -human chorionic gonadotrophin pregnancy test) at screening or pre-dose on Day 1.
    5.History of alcohol/drug abuse or dependence within 12 months of the study.
    6.Treatment with an investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of study medication.
    7.Subject has consumed 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.
    8.Subject has consumed liquid antacids (e.g. Maalox™, Mylanta™, Amphogel™, milk of magnesia), chewable antacids (e.g. TUMS™) or calcium supplements within 48 hours of the first dose of study medication, and/or will require these medications during the 6-week dosing period.
    9.Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements (See Exclusion 7 for calcium supplements), within 1 week of the study start. Subject has consumed rosuvastatin or pravastatin within 1 week of the first dose of study medication and/or will require these medications during the 6-week dosing period.
    10.History of platelet aggregation that prevents reliable measurement of platelet counts.
    11.Any laboratory or clinical evidence for HIV infection; any clinical history or laboratory evidence for hepatitis C infection; any clinical history or laboratory evidence for chronic hepatitis B 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.
    12.Previous participation in a clinical study with SB-497115-GR.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with a platelet count of  50,000/L after 42 days of dosing (compared to baseline count of < 30,000/L). Subjects who meet this criterion will be referred to as treatment responders.
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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.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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    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 Yes
    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
    LPLV
    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 2006-02-23. 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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 129
    F.4.2.2In the whole clinical trial 210
    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 Decision2006-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-02-21
    P. End of Trial
    P.End of Trial StatusCompleted
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