NCT00909584终止2 期
Phase 2 Randomized Study of Ezatiostat Hydrochloride (Telintra™, TLK199 Tablets) for Treatment of Severe Chronic Neutropenia
Telik4 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Objective absolute neutrophil count (ANC) response rate
研究概览
简要总结
This is a multicenter Phase 2 randomized parallel-group study to determine the effect of Telintra treatment on severe chronic neutropenia. Patients will be randomized to Telintra or enter an observation period with an option to crossover to Telintra treatment in a 1:1 allocation.
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
- None
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
- •Confirmed Idiopathic Severe Chronic Neutropenia
- •ECOG performance status of 0-2
- •Adequate liver and renal function
- •Adequate Red Blood Cell and Platelet counts
排除标准
- •Prior treatment of SCN
- •Non-Idiopathic types of SCN, ie. cyclic, congenital
- •History of chromosomal abnormalities, myelodysplasia, hematologic malignancy, aplastic anemia, systemic lupus erythematosus, rheumatoid arthritis (Felty's syndrome), or other collagen diseases, and drug-induced neutropenia, autoimmune neutropenia
- •Use of granulocyte colony stimulating factors (G-CSF), glucocorticoids, gamma globulin, lithium or investigational drug(s) within one month of enrollment
- •History of bone marrow transplantation or stem cell support
研究组 & 干预措施
1
Experimental
4-Week dose equilibration period with Telintra followed by 4 month treatment period
干预措施: Ezatiostat Hydrochloride (Drug)
结局指标
主要结局
Objective absolute neutrophil count (ANC) response rate
时间窗: 18 Months
次要结局
- FACT-N quality of life assessment(18 Months)
- Safety assessments(18 Months)
- Incidence of infections, oropharyngeal ulcers and antibiotic use(18 Months)
- Incidence and duration of hospitalizations(18 Months)
研究者
研究点 (4)
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