NCT05686759招募中3 期
A Phase 3b Study to Investigate the Safety and Efficacy of Undiluted Intravenous Infusion of I.V.-Hepabig Inj. in Post-liver Transplant Patients
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 8
- 主要终点
- Adverse events occurred during clinical trials
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of undiluted intravenous infusion of I.V.-Hepabig inj. in post-liver transplant patients
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
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 and <65 years at the time of signing the consent form
- •Subjects who had history of liver transplantation due to HBV-related end-stage liver disease such as cirrhosis, liver cancer and fulminant hepatic failure and received treatment for prevent hepatitis B recurrence
- •HBsAg(+) before liver transplantation
- •Subjects who have been received I.V.-Hepabig inj more than 3 times dose of 10,000International Unit/4weeks regimen
排除标准
- •Subject with history of anaphylaxis to any component of the investigational product
- •Pregnant or breast-feeding women
- •Deficiency of Immunoglobulin A
- •Clinically significant renal diseases (serum creatinine >2.0mg/dL, anuria, renal failure or on dialysis at screening)
- •Co-infection with Hepatitis A Virus, Hepatitis C Virus, or Human Immunodeficiency Virus
- •Subject with history of malignancy within the last 5 years (excluding primary liver cancer)
- •Subject received estrogen or hormone replacement therapy within 3 months before screening
- •HBsAg or HBeAg or HBV DNA positive at screening
- •Anti HBs titer less than below criteria at screening <150 IU/L for subject whose HBeAg and HBV DNA were negative(-) before liver transplantation >500 IU/L for subject whose HBeAg or HBV DNA were positive(+) before liver transplantation
- •Subject with history of drug abuse
- •Participated in another clinical study within 30 days (relative to the last dose of investigational product) before screening
- •Subject who are determined disqualified to join clinical trials by investigator
研究组 & 干预措施
Undiluted intravenous infusion of I.V.-Hepabig inj
Experimental
Undiluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit within approximately 30 minutes
干预措施: Undiluted I.V.-Hepabig inj(GC5103) (Biological)
Diluted intravenous infusion of I.V.-Hepabig inj
Active Comparator
Diluted intravenous infusion of I.V.-Hepabig inj 10,000 International Unit into Dextrose 5% in water within approximately 1 hour
干预措施: Diluted I.V.-Hepabig inj(GC5103) (Biological)
结局指标
主要结局
Adverse events occurred during clinical trials
时间窗: during 20 weeks post first Investigational product administration
Safety will be assessed throughout the study through clinical safety evaluations(Adverse events)
次要结局
- Positive rate of Hepatitis B Surface Antigen(HBsAg)(Screening, 0, 4, 8, 12, 16, and 20 weeks)
- Hepatitis B Surface Antibody(Anti HBs) titer(Screening, 0, 4, 8, 12, 16, and 20 weeks)
- Positive rate of Hepatitis B e Antigen(HBeAg)(Screening, 0, 4, 8, 12, 16, and 20 weeks)
- Positive rate of Hepatitis B Virus DNA(HBV DNA)(Screening, 0, 4, 8, 12, 16, and 20 weeks)
- Laboratory tests(Screening, 0, 4, 8, 12, 16, and 20 weeks)
- Vital signs(Screening, 0, 4, 8, 12, 16, and 20 weeks)
- Physical examination(Screening, 0, 4, 8, 12, 16, and 20 weeks)
研究者
研究点 (8)
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