CTRI/2020/05/024976尚未招募不适用
Thiopurines therapy in Inflammatory Bowel Disease: Role of a spectrum of metabolites and enzymes in predicting the response
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Shailesh
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- 1. Quantifying Thiopurine metabolites,TPMT,IMPDH,ITPase,HGPRT enzymes using LC-MS/MS
研究概览
简要总结
The overall aim of this project is to make use of the spectrum ofmetabolite profiles, the activity and concentrations of TPMT, ITPase, HGPRT andIMPDH in IBD patients on TP therapy in order to optimize therapy and predictresponders from non-responders, thus translating basic research to efficient,cost-effective patient care applicable in developing low-income countries.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with a definite diagnosis of Ulcerative Colitis (UC) or Crohn’s Disease (CD) being initiated on azathioprine/6-mercaptopurine/ 6Tioguanine therapy (designated as thiopurine (TP) therapy) as per standard accepted criteria will be included.
排除标准
- •Patients with CD or UC on biologicals, or immunosuppressives other than thiopurines
- •Subjects who have undergone total procto-coloctomy for UC
- •Evidence of colorectal dysplasia or malignancies
- •Patients in whom bowel surgery appears to be imminent
- •Congenital or acquired immunodeficiency, especially known HIV infections, or evidence of other immuno-compromised states
- •Patients ineligible in any way for TP therapy e.
- •known intolerance to the drug
- •Patients not providing written informed consent for inclusion
- •Planning to conceive in 17weeks after initiation of therapy.
结局指标
主要结局
1. Quantifying Thiopurine metabolites,TPMT,IMPDH,ITPase,HGPRT enzymes using LC-MS/MS
时间窗: All at the end of the study
2. Comparision of the metabloites and Enzyme levels in Responders and Non Responders
时间窗: All at the end of the study
次要结局
- 1. Quantifying Thiopurine metabolites,TPMT,IMPDH,ITPase,HGPRT enzymes using LC-MS/MS(After the initiation of the Therapy)
研究者
研究点 (1)
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