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临床试验/CTRI/2020/08/027022
CTRI/2020/08/027022尚未招募3 期

Dose evaluation, Population Pharmacokinetic and Pharmacogenetic profiling of Hydroxyurea in Pediatric patients suffering from Sickle Cell Disease in India â?? A randomized controlled study

ICMR New 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) Newly diagnosed patients of less than 18 years of age with sickle cell disease as characterized by three or more painful crisis over the period of 12 months and the requirement of 2 or more blood transfusions over the same period. Painful crisis is defined as a presence of pain for 4 or more hours requiring the intervention with any injectable analgesics.
  • b) Patients should be homozygous for sickle cell disease (HbSS).
  • c) 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 immunosuppressant drugs.
  • c) Patients with abnormal liver function tests.
  • d) Patients allergic to any drug provided during the study period.
  • e) Patients on drugs interfering with the metabolism of hydroxyurea.

研究者

发起方
ICMR New Delhi

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