NL-OMON42326撤回2 期
Therapy of Refractory Inhibitors with immUne Modulation in Patients with Hemophilia. The TRIUMPH trial - TRIUMPH trial
niversitair Medisch Centrum Utrecht0 个研究点目标入组 5 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 5
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adult patients with mild, moderate or severe hemophilia A with a current anti-FVIII inhibitor that have failed previous regular ITI, independent of titre height.
排除标准
- •- Patients with active, severe or uncontrolled infection
- •- HIV positivity and/or CD4 < 400 mm3/ml
- •- Significant hepatic dysfunction (total bilirubin * 30 µmol/l or transaminases * 2.5x upper normal limit)
- •- Significant renal dysfunction requiring hemodialysis
- •- Intolerance of exogenous protein administration
- •- Currently participating in interventional hemophilia studies
- •- Known uncontrolled toxicity for DMSO
- •- Any psychological, familial, sociological and/or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •- Life expectancy <3 years
- •- History of active cancer during the past 5 years, except basal carcinoma of the skin
研究者
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