Phase 3 Study of rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of rhTPO for the Treatment of Thrombocytopenia in Subjects With Chronic Liver Disease Undergoing Elective Invasive Procedures
This is a global, multicenter, randomized, double-blind, placebo-controlled study using recombinant human thrombopoietin stimulating factor ( rhTPO) to treat adults with Chronic liver disease-related thrombocytopenia (CLDT). The study will evaluate rhTPO efficacy in elevating platelet level and its safety in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce pre-procedural platelet transfusion needs and the requirements for rescue treatment for bleeding.
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名：Joe Wu
- 电话号码：+65 66796282
- 邮箱：joewu@3s-mibio.com
学习地点
-
-
-
Tbilisi、乔治亚州
- 主动，不招人
- Caucasus Medical Center LLC
-
Tbilisi、乔治亚州
- 招聘中
- Geo Hospitals LLC
-
接触：
- 电话号码：995555499144
- 邮箱：eimedashvili66@yahoo.com
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Subjects ≥18 years of age at Screening.
- Subjects with CLDT who have baseline platelet count of <50 × 10⁹/L.
- Subjects scheduled to undergo a permitted elective invasive procedure must have an adequate pre-procedural platelet count.
- Subjects with Child-Pugh Class A or B.
- Subjects with Eastern Cooperative Oncology Group (ECOG) performance status of graded 0 or 1.
Exclusion Criteria:
- Any history of bone marrow diseases that interferes with platelet production.
- Current malignancy including solid tumors and hematologic malignancies (except HCC).
- History of liver transplantation, (partial) hepatic resection, splenectomy, splenic artery embolization, or transjugular intrahepatic portosystemic shunt (TIPS).
- Past or present thrombosis or prothrombotic condition.
- Presence of congenital or acquired thrombophilia or bleeding disorders.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Match placebo
|
For subcutaneous injection once daily, for up to 5 or 7 days |
|
实验性的：rhTPO
|
For subcutaneous injection once daily, for up to 5 or 7 days |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Proportion of subjects who require no platelet transfusion prior to the elective invasive procedure and no rescue therapy for bleeding.
大体时间：22 days
|
22 days
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Proportion of subjects achieving the target platelet count from Baseline to Procedure Day before any platelet transfusion;
大体时间：8-15 days
|
8-15 days
|
|
Change in platelet count from Baseline to Pre-Procedural Assessment;
大体时间：8-14 days
|
8-14 days
|
合作者和调查者
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.