A Trial to Study the Influence of Growth Factors on Bone Marrow and Hepatic Regeneration in Patients With Decompensated Cirrhosis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis.
研究概览
简要总结
This will be a randomized double blind study which will be conducted on patients admitted to Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline.
60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30 patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1 year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg twice a week for 2 months.
Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3 months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-65 years
- •All patients who are known to have cirrhosis of liver with portal hypertension and are compensated on presentation with no features of ascites/ jaundice/ bleed/ HE/ HRS.
- •Only patients with alcoholic cirrhosis and cryptogenic cirrhosis (etiology work up negative) will be enrolled in the study.
排除标准
- •Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, LRTI)
- •Variceal bleed in the past 3 months
- •Autoimmune disorders
- •HCC (Hepatocellular Carcinoma)
- •Multi organ failure
- •Any features of decompensation in form of ascites/Jaundice/ HE (grade 3 or 4) / HRS
- •HIV seropositivity
- •Essential hypertension
- •Pregnancy
- •Refusal to participate in the study
研究组 & 干预措施
G-CSF + Erythropoietin
干预措施: G-CSF (Drug)
G-CSF
干预措施: G-CSF+Erythropoetin (Drug)
结局指标
主要结局
The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis.
时间窗: 1 Year
次要结局
- Histopathological evidence of hepatic regeneration and mobilization of CD34/stem cells(1 Year)
- Histopathological evidence of contribution of bone marrow precursor cells in hepatic regeneration and the markers predicting positive response to growth factors(1 Year)
- Development of new complications such as appearance or worsening of hepatic encephalopathy, hepatorenal syndrome and sepsis.(1 Year)
- Improvement in severity assessment scores and safety profile of G-CSF (Growth-Colony Stimulating Factor) + EPO (Erythropoetin)dual therapy vs. G-CSF alone.(1 Year)
- Transplant free survival at 6 months in both groups(6 months)