NCT01797276No Longer Available不适用
Dichloroacetate Treatment of Congenital Lactic Acidosis Phase B: Expanded Access
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 1
研究概览
简要总结
Expanded access to DCA as continued treatment for congenital lactic acidosis.
详细描述
Subjects who participated in a Phase 3 Randomized Controlled Trial of DCA for treatment of Congenital Lactic Acidosis (CLA) are eligible to continue treatment with investigational medication DCA at the same dose of 25mg/kg/day for expanded access. Study participants must travel to the study site for bi-annual evaluation by the study investigator. Bi-annual evaluation will include an interim medical history review, physical exam, blood collection for DCA trough level, and urine pregnancy testing (if indicated).
研究设计
- 研究类型
- Expanded Access
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of congenital lactic acidosis
- •Participation in Study: #183-1992: Dichloroacetate Treatment of Congenital Lactic Acidosis
排除标准
- •Intolerance to DCA
研究者
研究点 (1)
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