To Assess the Efficacy of Granulocyte Colony Stimulating Factor Versus Standard Medical Therapy in Patients of Decompensated Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 1
- 主要终点
- Number of participants alive at 6 months
研究概览
简要总结
Background and Aims: Liver transplantation is the only curative treatment modality for decompensated cirrhosis and is limited by donor organ availability and financial resources; thus many patients die while awaiting liver transplant. Granulocyte colony stimulating factor (GCSF) therapy can mobilize bone marrow stem cells for tissue regeneration, and has been shown to benefit patients with liver disease. The investigators evaluated the efficacy of GCSF therapy in decompensated cirrhosis in an open labelled randomized control trial.
Patients and Methods: Consecutive patients with decompensated cirrhosis of mixed etiologies were randomized to receive either a 5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months (Group-A); or standard medical therapy alone for 6 months (Group-B). At the end of 6 months their survival were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years to75 years
- •Patients of decompensated cirrhosis with CTP ≥6 and ≤ 13
- •Liver transplantation not feasible soon (due to financial reasons or unavailability of donors).
排除标准
- •Hepatocellular Carcinoma
- •Sepsis (Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP): Patients were included after sepsis is controlled.
- •Any organ failure
- •Grade 3 or 4 Hepatic Encephalopathy, Active Variceal bleed, Hepatorenal Syndrome: Patients might be included after clinical improvement
- •HIV seropositivity
- •Pregnancy
- •Refusal to participate in the study
- •Previous known hypersensitivity to G-CSF
研究组 & 干预措施
GCSF+SMT
5-day course of GCSF (5 μg/kg/d) plus standard medical therapy for 6 months
干预措施: Granulocyte Colony Stimulating Factor (Drug)
结局指标
主要结局
Number of participants alive at 6 months
时间窗: 6 months
次要结局
未报告次要终点
研究者
Dr. Ashish Kumar
Co investigator
Sir Ganga Ram Hospital