NCT02304315已完成2 期
A Randomized, Open-label, Single-center, Phase II Trial to Explore the Safety and Efficacy of GC1102 and Determine Its Optimal Dose After Intravenous Administration in HBV-related Liver Transplant Recipients
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recurrence rate of Hepatitis B
研究概览
简要总结
This is a proof-of-concept study for GC1102 to demonstrate preventing the recurrence of hepatitis B virus (HBV) infection following liver transplantation and a dose-finding study to determine its optional dose.
详细描述
GC1102 is a new recombinant hepatitis B immunoglobulin (HBIg) from Chinese Hamster Ovary (CHO) cells. It is a monoclonal antibody and has high affinity and avidity to hepatitis B surface antigen and several advantages compared to HBIg derived from blood plasma of human donors. Forty volunteers will participate in the study, receive 24-week treatment with low dose (50,000IU) of GC1102 or with high dose (80,000IU) and be followed up till 28 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
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Given written informed consent
- •Aged 19 - 65 years
- •Expected liver transplantation related to hepatitis B
- •Positive HBsAg
排除标准
- •Patients has participated in any other clinical trial within 30 days
- •Patients who are scheduled re-operation for liver transplantation
- •Patients with are co-infected with HAV, HCV or HIV
- •History of malignant tumor within 5 years except primary liver cancer
- •Patients with moderate or severe renal disorder (serum creatinine > 1.5 X ULM) or anuria, acute renal failure or dialysis
- •Patients who had experienced cardiovascular attack, myocardiac infarction, PTCA or coronary bypass or with angina, arrhythmia, or any other clinically meaningful valvular heart disease, cerebral infarction or cerebral hemorrhage within 6 months
- •History of anaphylaxis against active ingredient or excipients of study drug
- •Patients who had been vaccinated with parenteral live vaccine (measles vaccine, epidemic parotitis vaccine, rubella vaccine, cholera vaccine, chickenpox vaccine) within 3 months
- •Patients who had been treated with any other immuno globulin within 3 months
- •Pregnant or breast-feeding women
- •Women of childbearing potential who do not agree to use appropriate contraceptive methods (condom, an intrauterine device, oral contraceptive hormones, or a vasectomy of male sex partner) during this study
- •Alcohol or drug abuse within 6 months
- •Patients who has any clinically meaningful disease in investigator's judgement to prevent participating in this study
结局指标
主要结局
Recurrence rate of Hepatitis B
时间窗: 28 weeks
Seroconversion rate of HBsAg or HBeAg
次要结局
- Incidence rate of Anti-GC1102 Antibody(28 weeks)
- Seroconversion rate of HBsAg or HBeAg(28 weeks)
- Overall survival rate(28 weeks)
- Mutation rate of HBV DNA(28 weeks)
- Seroconversion time of HBsAg or HBeAg(28 weeks)
- Geometric mean titer (GMT) of HBV DNA(Day 6, 28, 59, 84, 112, 140, 158, 196)
- Histological findings of hepatic graft(Baseline)
研究者
研究点 (1)
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