Eltrombopag for Post Transplant Thrombocytopenia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Comparing the Efficacy of Eltrombopaq and Placebo
研究概览
简要总结
The goal of this clinical research study is to learn if eltrombopag can help to improve platelet counts in patients with low platelets after they have had a stem cell transplant. The safety of this drug will also be studied.
详细描述
The Study Drug:
Platelets are cells that help the blood clot. Platelet counts are often lower after receiving a stem cell transplant. When the number of platelets in your body gets too low, it can cause bleeding. Eltrombopag is designed to imitate a protein in your body that helps make platelets. This may help your platelet counts stay normal.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups:
- If you are in Group 1, you will receive eltrombopag.
- If you are in Group 2, you will receive a placebo. A placebo is a substance that looks like the study drug but has no active ingredients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >/= 35 days post HCT with Platelet count </= 20 x 10^9/l sustained for 7 days or patients are platelet transfusion dependent, and
- •Neutrophil count >/= 1.5 x 10^9/l anytime within the last seven days before enrollment. Patients can be on myeloid or erythroid growth factors for example filgrastim), and
- •Age >/= 18
排除标准
- •Recurrence or progression of primary malignancy after HCT
- •ALT >/= 2.5 times the ULN
- •Serum bilirubin >2mg/dl (unless due to Gilbert's syndrome)
- •Documented deep vein thrombosis within 1 year before enrollment on the study, except if upper arm thrombosis related to central venous catheters, within 3 months before enrollment on the study.
- •ECOG Performance status >2
- •Pregnancy: Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation. A woman of child-bearing potential is defined as a woman who has not been naturally post-menopausal for at least 12 consecutive months or with no previous surgical sterilization. A negative pregnancy test result will be required before any study drug is given.
研究组 & 干预措施
Eltrombopag
Starting dose 50 mg/day orally for 8 weeks
干预措施: Eltrombopag (Drug)
Placebo
Once a day orally for 8 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Comparing the Efficacy of Eltrombopaq and Placebo
时间窗: Baseline to Day 57
Comparison of the efficacy of eltrombopag and placebo in patients with thrombocytopenia post hematopoietic cell transplantation (HCT).
次要结局
未报告次要终点