EUCTR2004-000367-98-LV进行中（未招募）不适用
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.
GlaxoSmithKline Research and Development Limited0 个研究点目标入组 422 人开始时间: 2005年9月23日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 422
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
- 性别
- All
入选标准
- •1. Diagnosed with chronic ITP at least 6 months prior to screening for this study with a platelet count of <30,000 platelets/?L.
- •2. Refractory patients who have failed at least one previous treatment for chronic ITP, including corticosteroids, immunoglobulins, azathioprin, danazol, immunomodulators and/or splenectomy.
- •3. Subjects treated with maintenance corticosteroid therapy must be receiving a steroid dose that has been stable for at least 1 month.
- •4. No past history of myocardial infarction or clinically significant ECG findings at screening.
- •5. Normal PT and aPTT, no history of clotting disorder, other than ITP.
- •6. Male, or female subjects that agree to use acceptable methods of contraception [including an intrauterine device (IUD)] and two forms of barrier contraception if engaging in sexual intercourse for at least 7 days prior to the first dose of study medication and continuing until 30 days after the final dose of study medication.
- •7. Aged over 18 years.
- •8. A signed and dated written informed consent is obtained from the subject.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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.
- •2. History of thrombosis within the last year.
- •3. For female subjects, a positive serum or urine human chorionic gonadotrophin pregnancy test at screening or predose on Day 1.
- •4. For female subjects, no current hormone replacement therapy or current oral contraceptive use.
- •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. Consumption of aspirin, aspirin-containing compounds, salicylates, milk of magnesia, or nonsteroidal anti-inflammatories (NSAIDs) within 3 weeks of the study start and until the end of the study.
- •8. Consumption of substrates of the cytochrome P450 2C9 isozyme, including diclofenac, ibuprofen, meloxicam, naproxen, flurbiprofen, piroxicam, suprofen, tolbutamide, glipizide, losartan, irbesartan, glibenclamide, glimepiride, amitriptyline, celecoxib, fluoxetine, fluvastatin, glyburide, fluoxetine, fluvastatin, glyburide, nateglinide, phenytoin, rosiglitazone, tamoxifen, torsemide and S-warfarin.
- •9. Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements, within 1 week of the study start.
- •10. A complete blood count (CBC) and/or reticulocyte count outside the reference range, except for platelet count.
- •11. History of platelet aggregation that prevents reliable measurement of platelet counts.
- •12. History of infection with HIV, hepatitis B virus or hepatitis C virus.
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