NCT01820208已完成不适用
Efficacy of G-CSF in the Management of Steroid Non-responsive Severe Alcoholic Hepatitis. - A Double Blind Randomized Control Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Proportion of Survival of subjects in both group
研究概览
简要总结
After successful screening, first the investigators first treat patients of severe alcoholic hepatitis with steroids for 7 days. Patients who are found to be unresponsive as per Lille's score [>0.45] would be randomized into either placebo group or G-CSF group. Responders to steroids will continue on steroids for 28 days followed by 2 weeks of tapering. Non responders will be randomized to receive G-CSF for 28days.
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
- •Severe alcoholic hepatitis patients [Maddrey's score > 32] aged between 18 to 65 years.
排除标准
- •Presence of active infections
- •Acute GI bleed
- •Hepatorenal syndrome
- •Patient unwilling
- •Autoimmune hepatitis
- •Hepatitis B, Hepatitis C, HIV cases
- •Pregnancy
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)
干预措施: G-CSF (Drug)
G-CSF
Experimental
G-CSF would be given at a dose of 5 microgram/kg daily for 5 days followed by once in 3 days for a total of 12 doses.
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of Survival of subjects in both group
时间窗: 4 weeks and 12 weeks
次要结局
- Improvement in Child's score in steroid unresponsive patients with severe alcoholic hepatitis patients(4 weeks and 12 weeks)
- Improvement in MELD score in steroid unresponsive patients with severe alcoholic hepatitis patients(4 weeks and 12 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
Efficacy and Safety of G-CSF in Patients With Severe Alcoholic Hepatitis With Null or Partial Response to SteroidAlcoholic HepatitisNCT02442180Chuncheon Sacred Heart Hospital64
已完成
2 期
Evaluation of G-CSF (Colony Stimulating Factor) in Patients With Chronic Chagas CardiomyopathyChronic Chagasic MyocarditisNCT02154269Hospital Sao Rafael70
Unknown
2 期
Mesenchymal Stem Cells as First Treatment Line for Resistant Acute Graft Versus Host DiseaseGraft vs Host DiseaseNCT02770430Hospital de Clinicas de Porto Alegre90
已完成
1 期
Transhepatic arterial administration of G-CSF mobilized autologous peripheral blood CD34 positive cells in patients with hepatitis C virus-related decompensated liver cirrhosisDecompensated liver cirrhosis (Hepatitis C virus-related)JPRN-jRCTb070190052akamura Toru14
已完成
早期 1 期
GCSF Adjunct Therapy for Biliary AtresiaBiliary AtresiaNCT03395028Holterman, Ai-Xuan, M.D.6