跳至主要内容
临床试验/JPRN-jRCT2080224845
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)

Teijin Pharma Limited0 个研究点目标入组 27 人开始时间: 2019年8月23日最近更新:
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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