CTRI/2022/01/039317已完成4 期
Efficacy, Safety, and population pharmacokinetics of low-dose vs. standard dose hydroxyurea in paediatric patients suffering from Sickle cell disease: A randomized double-blind active-control non-inferiority clinical trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
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)Sickle cell Anemia patients between 6-18 years of age having weight between 15-60 years either on Hydroxyurea or are started on hydroxyurea and characterized by pain episodes in the past. Painful crisis is defined as a presence of pain for 4 or more hours requiring the intervention with any injectable analgesics.
- •b)Patients willing to provide informed consent and assent.
排除标准
- •a)Patients with other forms of sickle cell syndromes.
- •b)Patients on any immunosuppression drugs.
- •c)Patients with abnormal liver function tests.
- •d)Patients allergic to any drug provided during the study period.
研究者
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