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临床试验/NCT01634230
NCT01634230No Longer Available不适用

Emergency Use of OCR-002 (Ornithine Phenylacetate) in the Treatment of Patients With Acute Liver Failure

Ocera Therapeutics, Inc.1 个研究点 分布在 1 个国家开始时间: 2012年7月6日最近更新:
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

This study provides emergency use of the unapproved study medication in ALF patients with acute liver failure who are not responding to standard of care.

详细描述

This is an open-label study in patients diagnosed with ALF who are not responding to the institution's standards of care. Standard of care may include, but is not limited to, administration of N-acetylcysteine, lactulose, hypothermia therapy, and consideration for orthotopic liver transplant.

研究设计

研究类型
Expanded Access

入排标准

性别
All
接受健康志愿者

入选标准

  • International Normalized Ratio (INR) ≥1.5 with encephalopathy in patient with no prior history of liver disease
  • Venous ammonia level of ≥ 100 μmol/L

排除标准

  • Patients who are pregnant

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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Emergency Use of OCR-002 in Acute Liver Failure (ALF) | 临床试验