NCT03519113Unknown2 期
Dose Selection(Step 1), Non-inferiority(Step 2), Phase II/III Clinical Trials to Evaluated the Efficacy and Safety of Hepatitis B Virus-associated Liver Transplant Patients by Intravenously Injecting GC1102
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 186
- 试验地点
- 1
- 主要终点
- Prevention Failure rate of HBV
研究概览
简要总结
This is a clinical 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. Volunteers will participate in the study, receive 24-week treatment with 80,000/100,000 IU of GC1102 or I.V HBIG 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
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject who was informed of, and fully understood, all aspects of the study and has provided voluntary written consent for participation in the study
- •Subject aged over 19 years at the time of consent provided
- •Subject with planned liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure
- •Subject with HBsAg(+)
排除标准
- •Subject with planned reoperation following liver transplantation
- •Subject with hemophilia
- •Subject with a history of venous or arterial thrombosis
- •Subject with HAV, HCV or HIV infection
- •Subject with immunodeficiency or immunosuppression due to whole body steroids before liver transplantation
- •Subject with hemolytic or blood loss anemia
- •Subject with IgA deficiency
- •Subject with a history of malignant tumor within the last 5 years, excluding primary liver cancer
- •Subject with moderate to severe kidney disease (serum creatinine > 20mg/dL or anuria, kidney failure or dialysis)
- •Subject with a history of transient ischemic attack(TIA), myocardial infarction(MI), unstable angina, cerebral infarction, cerebral hemorrhage, percutaneous transluminal angioplasty(PTA) or coronary artery bypass graft(CABG) within the last 6 months prior to the screening
- •Subject with severe heart failure(NYHA class III~IV), arrythmia requiring treatment
- •Subject with known hypersensitivity (anaphylaxis) to any component of the study drug
- •Subject who had received other immunoglobulin product within the last 3 months prior to the study entry
- •Subject who had received live parenteral vaccine (MMR, Cholera and Varicella) within the last 3 months prior to the study entry
- •Subject who had received estrogen or hormone alternative medicine
- •Pregnant or breast-feeding women
- •Woman of childbearing potential with positive pregnancy test confirmed by serum beta-human chorionic gonadotropin(B-HCG) test within 28 days prior to dosing by urine pregnancy or Subject who refused to use a reliable method of contraception
- •Alcohol or drug abuse within 6 months
- •Subject who has participated in any other clinical trial within 30 days
- •Subject who has any clinically meaningful disease investigator's judgement to prevent participating in this study
研究组 & 干预措施
Test group 1
Experimental
GC1102 80,000 IU
干预措施: GC1102 80,000 IU (Biological)
Test group 2
Experimental
GC1102 100,000 IU
干预措施: GC1102 100,000 IU (Biological)
Control group
Active Comparator
I.V HBIG
干预措施: I.V HBIG (Biological)
结局指标
主要结局
Prevention Failure rate of HBV
时间窗: 28weeks
Seroconversion rate of HBsAg or HBeAg, anti-HBs \< 500 IU/L
次要结局
- Recurrence rate of HBV(28weeks)
- Geometric mean titer of HBV DNA(1 year)
- Prophylactic failure rate of HBV(28weeks)
- Overall survival rate(1 year)
- Recurrence duration(28weeks)
- Change of anti-HBe(1 year)
研究者
研究点 (1)
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