A Phase II, Multicenter, Randomized, Open-label Study to Investigate the Safety and Efficacy of Pegfilgrastim (Neulasta®) in Patients With Alcoholic Hepatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8)
研究概览
简要总结
This is a multi-center, prospective, randomized trial of standard of care vs. standard of care + pegfilgrastim (Neulasta®) among patients with a clinical diagnosis of alcoholic hepatitis and DF≥32.
详细描述
Standard of care treatment will be with either prednisolone 40 mg/day for 28 days or pentoxifylline 400 mg TID for 28 days. The patient's physician will decide the standard of care treatment the patient will receive. Patients will be randomized (1:1) to receive either no additional drug treatment (SOC group) or to receive a pegfilgrastim (Neulasta®, 6 mg) SQ.
Patients will be seen in-person at screening, randomization (Day 1), Day 8, Day 29, Week 12, and Week 24. Safety examination and blood tests will be performed. In addition, biological specimens will be saved for research purposes at these time points.
Total duration of patient participation is 24 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A clinical diagnosis of alcoholic hepatitis with Maddrey's discriminant function score ≥
- •Age 18 years or older.
排除标准
- •Renal failure (creatinine >2.0 mg/dl)
- •Bilirubin <5 mg/dL
- •uncontrolled recent upper gastrointestinal bleeding
- •Known HIV infection
- •Uncontrolled infection, or pregnant.
研究组 & 干预措施
prednisolone or pentoxifylline + pegfiltrastim
prednisolone or pentoxifylline for 28 days PO plus pegfilgrastim subcutaneous weekly shot
干预措施: Standard of care + pegfiltrastim (Drug)
prednisolone or pentoxifylline
prednisolone or pentoxifylline for 28 days
干预措施: Standard of care (Drug)
结局指标
主要结局
Adverse events, especially infection and renal failure, Change in MELD Score and DF between Day 1 and Day 29, Lille score (at Day 8)
时间窗: Day 1, Day 8, Day 29, and Day 90
The primary outcome will be survival at Day 90. Assuming a fixed sample size of 70 patients (35 per arm), a one-sided z-test will have 81.6% power to detect a 25% improvement in survival proportions between arms, with survival in the standard of care arm at 65%.
次要结局
- adverse events(24 weeks)
- Liver function(Day 29)
- liver function(Day 8)
- Survival(at Day 90)
研究者
Timothy Morgan, MD
Chief of Hepatology
Southern California Institute for Research and Education