JPRN-jRCT2080225030已完成2 期
Phase II clinical study of OP-07 in patients with delayed excretion of methotrexate after HD-MTX administration
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
研究概览
简要总结
Glucarpidase caused a decrease in the blood MTX concentration at 20 minutes after the drug administration, and all subjects achieved the CIR. There were also no safety problems as suggested by the incidence of adverse events attributable to this product.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- ot applicable 至 ot applicable（—）
- 性别
- All
入选标准
- •1) A written consent for participation in the clinical study was obtained by patients themselves or their legal representative
- •2) Fifteen hours or more have passed since administration of MTX and one of the following criterion
- •(1) to (4) is met:
- •(1) a blood MTX concentration > 50 umol/L at 22 hours or more after the start of MTX infusion
- •(2) a blood MTX concentration > 5 umol/L at 40 hours or more after the start of MTX infusion
- •(3) a blood MTX concentration > 2 umol/L at 46 hours or more after the start of MTX infusion
- •(4) a blood MTX concentration > 1 umol/L at 40 hours or more after the start of MTX infusion, and have a sign of acute renal failure*.
- •* Acute renal failure is defined as meeting either of the following (i) to (iii):
- •(i) The serum creatinine after the start of MTX administration is higher than the upper limit of the pediatric reference in the site (if absent, Toshiaki Tanaka, Pocket Guide for Reference Laboratory Values in Children, second edition, Jiho)
- •(ii) Increase to 1.5 times or more the serum creatinine before the start of MTX administration
- •(iii) Increase of 0.3 mg/dL or more in the serum creatinine within 48 hours before enrollment
排除标准
- •1) Subjects who have a history of hypersensitivity against contained excipients (lactose hydrate, trometamol, zinc acetate dihydrate, and hydrochloric acid)
- •2) Subjects who are using loop diuretics or mannitol, and can't discontinue them
- •3) Subjects who are recieved hemodialysis or plasmapharesis, and can't discontinue them
- •4) Subjects who are recieved MTX (any route of administration) after IV HD-MTX
- •5) Subjects who are previously treated with investigational drug
- •6) Subjects with severe cardiac disease
- •7) Subjects who are pregnant or nursing, and can't prevent conception during follow-up period
- •8) Subjects who are judged to be inappropriate by investigator
研究者
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