JPRN-jRCTs031180089已完成1 期
Clinical Trial of Immunomodulatory Therapy Using Anti-Thymocyte Globulin and Pegfilgrastim for Recently Onset Type 1 Diabetes - CRITICA
CHUJO DAISUKE0 个研究点目标入组 12 人开始时间: 2019年1月18日最近更新:
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
简要总结
We evaluated the safety and efficacy of immunomodulatory therapy using anti-thymocyte globulin and pegfilgrastim in recently onset type 1 diabetes. In terms of safety, no grade 4 and 5 severe adverse events were observed. In terms of efficacy, although some analyses showed potantial effects for the preservation of endogenous insulin secretion, the results were not significant. In the future, the efficacy of the treatment should be validated in the trial with more ceses.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 65age old(—)
- 性别
- All
入选标准
- •1. Acute-onset type 1 diabetes
- •2. Within 12 months since diagnosis
- •3. Fasting serum C-peptide > 0.3 ng/m
排除标准
- •1. Active infection
- •2. Pregnancy/breast-feeding
- •3. Past history of malignant tumor
- •4. Interstitial pneumonia
- •5. Severe liver or/and kidney dysfunction
- •6. Past history of ATG administration
- •7. Under systemic steroid therapy
研究者
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