EUCTR2018-000452-18-ES进行中（未招募）1 期
A phase II, open-label, prospective, single-arm, study to assess ability of eltrombopag to induce sustained remission in subjects with ITP who are refractory or relapsed after first-line steroids (TAPER)
ovartis Farmacéutica, S.A.0 个研究点目标入组 101 人开始时间: 2018年8月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 101
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. Signed informed consent must be obtained prior to participation in the study
- •2. Subjects = 18 years old
- •3. Subjects with a confirmed diagnosis of primary ITP, who are not responsive or in relapse after a first line of steroid therapy ± intravenous immunoglobulin (IVIG) (used as a rescue therapy)
- •4. Platelet count < 30×109/L and assessed as needing treatment (per physician’s discretion
- •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 66
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 35
排除标准
- •1. ITP subjects previously treated with any ITP second-line therapies, thrombopoietin receptor (TPO-R) agonists for ITP, except steroids / IVIG
- •2. Subjects who relapsed more than one year after the end of first-line full course of steroid therapy
- •3. Subjects with a diagnosis of secondary thrombocytopenia
- •4. Subjects who have life threatening bleeding complications per investigator discretion
- •5. Subjects who had a deep vein thrombosis or arterial thrombosis in the 6 months preceding enrollment
- •6. Serum creatinine = 1.5 mg/dL
- •7. Total bilirubin > 1.5 × upper limit of normal (ULN)
- •8. Aspartate transaminase (AST) > 3.0 × ULN
- •9. Alanine transaminase (ALT) > 3.0 × ULN
- •10. Subjects who are human immune deficiency virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg) positive
- •11. Subjects with hepatic impairment (Child-Pugh score > 5)
- •12. Subjects who have active malignancy
- •13. Subjects with any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions that could interfere with subject’s safety, obtaining informed consent or compliance with the study procedures per investigator discretion
- •14. History or current diagnosis of cardiac disease indicating significant risk of safety for subjects participating in the study
- •15. Subjects with known active or uncontrolled infections not responding to appropriate therapy
- •16. Subjects with evidence of current alcohol/drug abuse
- •17. Women of child-bearing potential and sexually active males unwilling to use adequate contraception during the study
- •18. Female subjects who are nursing or pregnant (positive serum or urine B-human chorionic gonadotrophin (B-hCG) pregnancy test) at screening or pre-dose on Day 1
- •Other protocol-defined inclusion/exclusion criteria may apply
研究者
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