An Open, Prospective, Single Arm Study Investigating Efficacy and Safety of Human Hepatitis B Immunoglobulin Zutectra in Liver Transplanted Patients - the ZEUS Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biotest
- 入组人数
- 49
- 试验地点
- 16
- 主要终点
- Trough levels of serum anti-HBs antibody concentrations
研究概览
简要总结
Patients who receive liver transplantation for hepatitis B virus (HBV) induced liver failure require longterm therapy to prevent HBV reinfection of the transplanted liver. The approved preventative treatment is a combination of antihepatitis B immunoglobulin (HBIg) and oral antiviral medication. In the first 6 months after liver transplantation, patients receive treatment with intravenous HBIg to maintain blood antihepatitis B (antiHBs)antibody concentrations above 100 IU/L, the level considered safe for preventing hepatitis B reinfection.
Zutectra is an HBIg preparation for subcutaneous injection that is approved in the EU for the 'prevention of HBV reinfection in HBV DNA negative patients ≥ 6 months after liver transplantation for hepatitis B induced liver failure'. The purpose of this study is to show that earlier subcutaneous HBIg treatment with Zutectra after liver transplantation can prevent hepatitis B reinfection.
Treatment with subcutaneous HBIg (Zutectra) at home is manageable for the majority of patients and is more convenient for patients compared to intravenous treatment that must take place in the hospital setting.
Fourty patients will take part in the study at approximately 19 centres in UK, France, Italy and Spain. Patients who are eligible for the study will receive treatment with Zutectra for 24 weeks.
During the study, the safety and effectiveness of Zutectra will be assessed by checking for symptoms of hepatitis B related infection, as well as monitoring blood levels of antiHBs antibodies and hepatitis B surface antigen (HBsAg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent obtained prior to orthotopic liver transplantation (OLT) - not more than 3 months before OLT
- •Historical evidence within the last 4 weeks that HBV-DNA is undetectable at time point of signature of Informed Consent
- •Male and female patients (age 18-75 years)
- •Patients with the diagnosis of liver failure with hepatitis B infection
- •Patients undergoing liver transplantation or re-transplantation
- •HBsAg negative on day 7 or on day 14 after OLT
- •HBV-DNA undetectable at OLT
- •Serum HBs antibody concentration on day 7 or on day 14 after OLT ≥ 400 IU/l
- •Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study
- •Willingness to fill out patient diary
排除标准
- •Re-transplantation due to viral recurrence
- •Positive HIV or HCV test at time of transplantation
- •HBV-DNA positive at OLT
- •Patients having received organs from HBsAg positive donors
- •Pregnancy or unreliable contraceptive measures or lactation period (females only)
- •Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)
- •Known intolerance to proteins of human origin
- •Participation in another interventional clinical trial within 90 days before entering the study or during the study and/or previous participation in this study (except screening failures)
- •Suspicion of drug and/or alcohol abuse
- •Inability or lacking motivation to participate in the study
- •Employee or direct relative of an employee of the CRO, the study site, or Biotest
研究组 & 干预措施
Zutectra
Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.
干预措施: Zutectra (Drug)
结局指标
主要结局
Trough levels of serum anti-HBs antibody concentrations
时间窗: 24 weeks
次要结局
- Hepatitis B related re-infections(24 weeks)