Double-blind placebo-controlled clinical trial of thalidomide for chronic granulomatous disease-associated colitis

Kawai Toshinao0 个研究点目标入组 8 人开始时间: 2020年12月10日最近更新: 2023年10月17日

试验速览

暂无简介。

•1) Diagnosis of CGD colitis, ages over one year
•2) Moderate CGD colitis (35 /<= PUCAI < 65), or Mild CGD colitis (10 /<= PUCAI <35) carrying bloody stool or over six times of defecation at the onset or relapse
•3) Signed informed consent form agreeing to the clinical trial participation
•4) Informed consent to compliance rules including administration of investigational agent and contraception

•1) Patients allergic to the drug ingredients
•2) Patients with HIV infection
•3) Cancer except granuloma
•4) Macrophage activating syndrome
•5) Any mental problem
•6) Pregnant or breast-feeding woman
•7) Taking thalidomide or having a history of thalidomide administration
•8) Oral, intravenous, or enema administration of steroid within four weeks of providing informed consent
•9) Administration of immunomodulator within eight weeks of providing informed consent
•10) A history of any biological agent administration
•11) Miner who do not have guardian for appropriate administration of investigational agent
•12) In certain circumstances that the researchers determined it was not suitable for the research

发起方

Kawai Toshinao