NCT00724334已完成1 期
An Open-Label Study to Evaluate the Long-Term Effects of Orally Administered SAR302503 in Patients With Primary or Secondary Myelofibrosis
Bristol-Myers Squibb6 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2008年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 6
- 主要终点
- Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability
研究概览
简要总结
The purpose of this study is to evaluate the long-term effects of orally administered SAR302503 (TG101348) in patients with myelofibrosis who have completed the MF-TG101348-001 study.
详细描述
SAR302503 (TG101348) is a potent small molecule inhibitor of Janus kinase 2 (JAK2). This is an extension study for a first-in-man, dose escalation study (MF-TG101348-001). The safety, tolerability and clinical activity of SAR302503 (TG101348) in subjects with myelofibrosis will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Completion of MF-TG101348-001 study
- •Diagnosis of myelofibrosis
- •At least 18 years of age
排除标准
- •Any acute or chronic medical abnormality that may increase the risk associated with study participation
研究组 & 干预措施
1
Experimental
干预措施: SAR302503 (TG101348) (Drug)
结局指标
主要结局
Safety (i.e. adverse events, effects on laboratory parameters, vital signs and ECGs) and tolerability
时间窗: 6 months
次要结局
- Clinical activity and pharmacodynamics(6 months)
研究者
研究点 (6)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1BUsher's SyndromeNCT02065011Sanofi9
进行中（未招募）
2 期
Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular DegenerationStargardt's DiseaseNCT01736592Sanofi27
已完成
3 期
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and OlderCystic FibrosisNCT05153317Vertex Pharmaceuticals Incorporated71
进行中（未招募）
3 期
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and OlderCystic FibrosisNCT06460506Vertex Pharmaceuticals Incorporated50
已完成
2 期
A Long Term Safety Study of BCX7353 in Hereditary AngioedemaHAEProphylaxisHereditary AngioedemaNCT03472040BioCryst Pharmaceuticals387