Intervention study on autoimmune bullous diseases with imatinib - IABD

Kabashima Kenji0 个研究点目标入组 12 人开始时间: 2019年2月19日最近更新: 2023年10月17日

适应症

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 12

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

The standard treatment for autoimmune bullous diseases is systemic glucocorticoids. This treatment causes serious side effects such as compromised infections that can result in death. This study evaluated whether systemic imatinib could ameliorate autoimmune bullous diseases. Beneficial effect with the additive seven day-administration of imatinib on the standard glucocorticoid-based treatment was unapparent. The reason for this may be the short duration of imatinib administration.

研究设计

研究类型: Interventional

入排标准

年龄范围: >= 20age old 至 < 100age old（—）
性别: All

入选标准

•Eligibility (inclusion) criteria
•1) Diagnosed as pemphigus group or pemphigoid group.
•2) Those who are not expected to be treated with pulse steroid therapy or intravenous immunoglobulin (IVIG).
•3) The age at the time of consent acquisition is 20 or over 20 years old.
•4) The latest blood test and liver function test within 4 weeks before registration satisfy all of the following:
•Neutrophil count >= 1,500/mm3; platelet count >= 75,000/mm3; AST (GOT) < 120 IU/L; ALT(GPT) < 120 IU/L; total bilirubin < 1.8 mg/dL.
•5) Males, those agreeing to contraception for 4 weeks from the start of the test drug administration to the final administration day of the test drug. Females, those after surgical contraceptive surgery such as postmenopausal (more than one year since the last menstruation), or bilateral oophorectomy.
•6) Written informed consent by the patient has been obtained.

排除标准

•Exclusion criteria
•1) No history of allergy to Imatinib.
•2) Those who have one of the following complications:
•Serious heart disease, serious liver disorder, serious renal disorder or past history of such conditions.
•3) Those who had given consent of participation in other trials within 4 weeks before the acquisition of this study.
•4) Those who are judged to be unsuitable for carrying out this study by the investigator or shared medical doctors.

研究者

发起方

Kabashima Kenji

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