PER-084-06已完成未知
EXTEND (STUDY FOR THE EXTENDED DOSAGE OF ELTROMBOPAG): STUDY OF EXTENSION OF ELTROMBOPAG OLAMINE (SB-497115-GR) IN ADULTS WITH IDIOPATIC THROMBOCYTOPENIC PURPURA (ITP) PREVIOUSLY ENROLLED IN A STUDY WITH ELTROMBOPAG
GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 5 人开始时间: 2006年11月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •1. The subject has signed the written informed consent form.
- •2. Adults (≥18 years) with a diagnosis of ITP.
- •3. Randomization and previous termination of treatment and follow-up periods in any of the studies of eltrombopag for ITP.
- •4. The subjects previously recruited in the TRA 100773 study must have completed the prescribed ophthalmic evaluation at 6-month follow-up without having found any ocular event of clinical concern.
- •5. Subjects previously recruited in the TRA 102537 RAISE Study must have completed the treatment and follow-up periods defined in that protocol.
- •6. Subjects who have not experienced any EAS related to eltrombopag or any intolerance to any other medication in previous studies of eltrombopag.
- •7. Subjects who do not have any intercurrent medical event.
- •8. Ophthalmological examinations performed in previous studies that have not identified ocular events of clinical concern.
- •9. Subjects must have had an initial response to a previous treatment for ITP or have had a bone marrow biopsy compatible with ITP in the previous 3 years to rule out myelodysplasia or some other cause of thrombocytopenia.
- •10. Previous treatments for PTI with immunoglobulins and cyclophosphamide that have been completed at least 4 weeks before Day 1.
- •11. Subjects treated with corticosteroids should be receiving a dose that has been stable at least 1 month before Day 1 of the study.
- •12. Normal prothrombin time (TP and INR) and activated partial thromboplastin time (aPTT) also normal, with no history of any hypercoagulable state.
- •13. Complete blood count (CBC), within the reference intervals.
- •14. The following blood chemistry values should be within the normal reference values: creatinine, ALT, AST, total bilirubin, total albumin and alkaline phosphatase.
- •15. The subject practices some acceptable contraceptive method. Women (or female partners of male subjects) must not be of childbearing age, or be of childbearing age and use some acceptable contraceptive method from two weeks before the study drug administration, throughout the study and up to 28 days after completing the study or having been withdrawn prematurely.
- •16. The subject has the ability to understand and adhere to the requirements and instructions of the protocol.
排除标准
- •1. Any abnormality of clinical relevance, different from the PTI or any other problem or medical circumstance that makes the subject not suitable to participate in the study or indicate another diagnosis.
- •2. History of malignancy.
- •3. History of arterial or venous thrombosis.
- •4. History of arterial or venous thrombosis AND ≥ 2 of the following risk factors: Leiden Factor V, hormone replacement therapy, systemic contraceptives, smoking, diabetes, hypercholesterolemia, antihypertensive medications or cancer.
- •5. Pre-existing heart disease or clinically important findings on the resting ECG of 12 leads.
- •6. Lactating or pregnant women.
- •7. History of alcohol or drug abuse.
- •8. Treatment with a product under investigation in the previous 30 days or five half-lives (whichever is longer) before the first dose of study medication.
- •9. Subjects treated with aspirin, compounds containing aspirin, salicylates, anticoagulants, quinine or nonsteroidal anti-inflammatory drugs (NSAIDs) for> 3 consecutive days in the 2 weeks prior to the start of the study and until the end of it.
- •10. Consumption of any herbal or dietary supplement.
- •11. History of alterations in platelet aggregation.
- •12. All subjects with secondary immune thrombocytopenia.
- •13. Subject who is planning to undergo cataract surgery.
- •14. In France, a person who is not affiliated with or is a beneficiary of any category of social insurance.
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