NCT01341951Unknown不适用
G-CSF in Acute Liver Failure and Alcoholic Hepatitis - A Pilot Study
Post Graduate Institute of Medical Education and Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- • Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization
研究概览
简要总结
Granulocyte colony stimulating factor in acute liver failure and alcoholic hepatitis
详细描述
In this study 4 groups have been taken. Two groups of cases including Alcoholic patients and acute liver failure which are given G-CSF therapy and two groups of controls given standard therapy. Primary end point is to see the mobilization of CD-34 hematopoietic cells and survival. Secondary end point is to see the clinical and biochemical improvement in liver functions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Acute Liver failure as defined by AASLD.65
- •Patients with Alcoholic hepatitis defined as follows: decades of heavy alcohol use (mean intake, approximately 100 g per day).The combination of an aspartate aminotransferase level that is elevated (but <300 IU per milliliter) and a ratio of the aspartate aminotransferase level to the alanine aminotransferase level that is more than 2, a total serum bilirubin level of more than 5 mg per deciliter (86 μmol per liter), an elevated INR, and neutrophilia.
排除标准
- •Known hypersensitivity to filgrastim
- •creatinine > 150 µmol/L
- •infection or hemorrhage within the last 10 days
- •documented hepatocellular carcinoma
- •hepatitis B,C or human immunodeficiency virus seropositivity and pregnancy
研究组 & 干预措施
G-CSF therapy in acute liver failure and alcoholic hepatitis
Experimental
G-CSF therapy given in cases with acute liver failure and alcoholic hepatitis
干预措施: Granulocyte colony stimulating factor (Drug)
结局指标
主要结局
• Mobilization of CD34 cells in the peripheral blood, a surrogate marker for hematopoietic stem cell mobilization
时间窗: 1 year
次要结局
- clinical and biochemical improvement in liver functions(1 year)
研究者
研究点 (1)
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