Clinical Evaluation of SB-497115-GR in Chronic Idiopathic Thrombocytopenic Purpura (ITP) -A Multicenter Study in Subjects With Chronic ITP Receiving a Double-Blind, Placebo-Controlled, Short-Term Treatment Followed by an Open-Label, Uncontrolled, Long-Term Treatment- <Phase II/III Study>
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Percentage of Participants for Whom at Least 75% of Their Assessments During the Course of 26 Weeks of SB-497115-GR Treatment Met the Definition of Responders
研究概览
简要总结
This is a Phase II/III multicenter study comprising of the double-blind, followed by open-label phases to evaluate and compare the efficacy and tolerability of eltrombopag (SB-497115-GR) in chronic ITP patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SB-497115-GR group
Subject will initiate treatment with SB-497115-GR 12.5mg once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR may be adjusted at 12.5mg, 25mg or 50mg.
干预措施: SB-497115-GR 12.5mg (Drug)
SB-497115-GR group
Subject will initiate treatment with SB-497115-GR 12.5mg once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR may be adjusted at 12.5mg, 25mg or 50mg.
干预措施: SB-497115-GR 25mg (Drug)
SB-497115-GR group
Subject will initiate treatment with SB-497115-GR 12.5mg once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR may be adjusted at 12.5mg, 25mg or 50mg.
干预措施: SB-497115-GR 50 mg (Drug)
placebo group
Subject will initiate treatment with SB-497115-GR 12.5mg matching placebo once a day. Based on the subjects platelet count at each visit, the dose of SB-497115-GR 12.5mg matching placebo may be increased to 2 tablet of SB-497115-GR 12.5mg matching placebo.
干预措施: SB-497115-GR 12.5mg matching placebo (Drug)
结局指标
主要结局
Percentage of Participants for Whom at Least 75% of Their Assessments During the Course of 26 Weeks of SB-497115-GR Treatment Met the Definition of Responders
时间窗: Week 26
A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter). Participants receiving placebo in the double-blind phase received SB-497115-GR in the open-label phase for up to 26 weeks. Participants receiving SB-497115-GR in the double-blind phase for 7 weeks continued to receive SB-497115-GR in the open-label phase for 19 weeks. The data from these two groups were pooled as a 26 week treatment of SB-497115-GR group and analyzed for the efficacy and safety.
Number of Responders at Week 6
时间窗: Week 6
A responder was defined as a participant with a platelet count within the target range (\>=50 x 10\^9/Liter and \<=400 x 10\^9/Liter).
次要结局
- Number of Participants at Baseline and Days 8, 15, 22, 29, 36, and 43 of Treatment by Platelet Count Category(Baseline and Days 8, 15, 22, 29, 36, and 43)
- Number of Participants Assessed as Responders in at Least 4 Assessments Between Weeks 2 and 6(Weeks 2 through 6)
- Percentage of Responders at Each Visit(Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26)
- Percentage of Participants With Bleeding Episodes Since the Last Visit(Days 1, 8, 15, 22, 29, 36, and 43)
- Mean Platelet Counts of Participants at Each Visit(Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26)
- Pharmacokinetics of SB-497115-GR, Cmax(Week 9 or 10)
- Pharmacokinetics of SB-497115-GR, Tmax(Week 9 or 10)
- Mean Total Time for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter(Weeks 1 through 26)
- Percentage of Participants With Bleeding Episode Since the Last Visit(Days 1, 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26)
- Pharmacokinetics of SB-497115-GR, Lambda z(Week 9 or 10)
- Pharmacokinetics of SB-497115-GR, CL/F(Week 9 or 10)
- Mean Platelet Count at Each Visit(Baseline and Days 8, 15, 22, 29, 36, and 43)
- Mean Change From Baseline in Platelet Counts at Each Visit(Baseline; Days 8, 15, 22, 29, 36, and 43; Weeks 10, 14, 18, 22, and 26)
- Percentage of Participants With a Reduction in Dose and/or Number of Drugs of Concomitant ITP Medications From Baseline(Baseline through Week 26)
- Mean Number of Days of Concomitant ITP Medication Use Per Month(Weeks 1 through 26)
- Pharmacokinetics of SB-497115, t1/2(Week 9 or 10)
- Pharmacokinetics of SB-497115-GR, AUClast and AUC0-24(Week 9 or 10)
- Mean Maximum Duration for Which Participants Maintained Platelet Counts >=50 x 10^9/Liter and <=400 x 10^9/Liter(Weeks 1 through 26)
- Percentage of Participants Who Received Rescue Treatment for ITP(Weeks 1 through 26)
- Pharmacokinetics of SB-497115-GR, Vz/F(Week 9 or 10)