EUCTR2006-000471-14-GB进行中（未招募）1 期
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 - EXTEND
GlaxoSmithKline Research and Development Limited0 个研究点目标入组 302 人开始时间: 2007年6月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 302
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
- •thrombocytopenia.
- •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
- •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 IT
排除标准
- •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 ß-human
- •chorionic gonadotrophin (ß-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
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