CTRI/2023/12/060945尚未招募3 期
Safety and efficacy of combination of thalidomide and hydroxyurea in children with transfusion dependent thalassemia: A phase III, multicentric, double-blind randomized placebo-controlled trial. - NI
ICMR, Delhi0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
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
入选标准
- •a.Children aged 2-18 years.
- •b.Diagnosis of transfusion dependent thalassemia, requiring regular blood transfusions.
- •c.Willing for regular follow up as required for the study
- •d.Informed consent given
- •e.Patients with child bearing potential must be willing for contraception (wherever applicable)
排除标准
- •a.Patients with hypersplenism and planning splenectomy during the next year
- •b.Patients planning for hematopoietic stem cell transplantation (HSCT)
- •c.Retroviral infection
- •d.Chronic active hepatitis (Hepatitis B or Hepatitis C)
- •e.Elevation of transaminases more than 5 times of upper limit of normal
- •f.Renal failure
- •g.Symptomatic cardiac failure and LVEF < 50%
- •h.Past history of stroke
- •i.Received hydroxyurea, thalidomide or luspatercept in the previous 6 months
- •j.Pregnancy or lactation
研究者
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