EUCTR2018-000452-18-GB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)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 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 patients previously treated with any ITP second-line therapies,
- •thrombopoietin receptor (TPO-R) agonists for ITP, except steroids /
- •2. Patients who relapsed more than one year after the end of first-line
- •full course of steroid therapy
- •3. Patients with a diagnosis of secondary thrombocytopenia
- •4. Patients who are unable to participate in assessments/biological
- •5. Patients who have life threatening bleeding complications per
- •investigator discretion
- •6. Patients who had a deep vein thrombosis or arterial thrombosis in the
- •6 months preceding enrollment
- •7. Presence of moderate to severe impaired renal function as indicated
- •by any or all of the following criteria:
- •? Creatinine clearance < 45 mL/min as calculated using Cockcroft-Gault
- •? Serum creatinine > 1.5 mg/dL
- •8. Total bilirubin > 1.5 × upper limit of normal (ULN)
- •9. Aspartate transaminase (AST) > 3.0 × ULN
- •10. Alanine transaminase (ALT) > 3.0 × ULN
- •11. Subjects who are human immune deficiency virus (HIV), hepatitis C
- •virus (HCV), hepatitis B surface antigen (HBsAg) positive
- •12. Subjects with hepatic impairment (Child-Pugh score > 5)
- •13. Subjects who have active malignancy
- •14. 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
- •15. History or current diagnosis of cardiac disease indicating significant
- •risk of safety for subjects participating in the study
- •16. Subjects with known active or uncontrolled infections not responding
- •to appropriate therapy
- •17. Subjects with evidence of current alcohol/drug abuse
- •18. Women of child-bearing potential and sexually active males unwilling
- •to use adequate contraception during the study
- •19. 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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