JPRN-jRCT2080224845已完成2 期
A Multi-center, Open-label, Non-controlled Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TMX-67 after Oral Administration in Hyperuricemic Pediatric Patients with or without Gout (Extension Study)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 27
研究概览
简要总结
In pediatric patients with hyperuricemia including gout, safety, efficacy, and pharmacokinetics of 52-week multiple oral doses of TMX-67 were investigated in an open-label and uncontrolled design. As a result, serum uric acid decreased with increase of TMX-67 dose and maintained serum uric acid of <= 6.0 mg/dL or around 6.0 mg/dL for a long term until Week 52. No significant concern was identified for long-term safety until Week 52.
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
- •Hyperuricemic pediatric patients with or without gout ,who completed the observation for 34 weeks of Study TMX-67HK-201.
排除标准
- •Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study
研究者
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