EUCTR2012-002516-51-IT进行中（未招募）不适用
An open, prospective, single arm study investigating efficacy and safety ofhuman hepatitis B immunoglobulin Zutectra in liver transplanted patients - the ZEUS Study - The ZEUS Study
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- BIOTEST AG
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written informed consent obtained prior to orthotopic liver transplantation (OLT) - not more than 3 months before OLT 2. Historical evidence within the last 4 weeks that HBV-DNA is undetectable at time point of signature of Informed Consent 3. Male and female patients (age 18-75 years) 4. Patients with the diagnosis of liver failure with hepatitis B infection 5. Patients undergoing liver transplantation or re-transplantation 6. HBsAg negative on day 7 or on day 14 after OLT 7. HBV-DNA undetectable at OLT 8. Serum HBs antibody concentration on day 7 or on day 14 after OLT = 400 IU/l 9. Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study 10. Willingness to fill out patient diary
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Re-transplantation due to viral recurrence 2. Positive HIV or HCV test at time of transplantation 3. HBV-DNA positive at OLT 4. Patients having received organs from HBsAg positive donors 5. Pregnancy or unreliable contraceptive measures or lactation period (females only) 6. Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction) 7. Known intolerance to proteins of human origin 8. 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) 9. Suspicion of drug and/or alcohol abuse 10. Inability or lacking motivation to participate in the study 11. Employee or direct relative of an employee of the CRO, the study site, or Biotest
研究者
相似试验
进行中（未招募）
不适用
A clinical trial of Zutectra in patients who recently received a liver transplantEnsayo Clínico de Zutreca en pacientes que se han sometido a un trasplante de hígadoHepatitis B re-infecciónHepatitis B re-infectionMedDRA version: 14.1Level: LLTClassification code 10058827Term: Hepatitis B reactivationSystem Organ Class: 100000004862EUCTR2012-002516-51-ESBiotest AG60
进行中（未招募）
1 期
A clinical trial of Zutectra in patients who recently received a liver transplantHepatitis B re-infectionMedDRA version: 20.1 Level: PT Classification code 10058827 Term: Hepatitis B reactivation System Organ Class: 10021881 - Infections and infestationsEUCTR2012-002516-51-GBBiotest AG60
进行中（未招募）
不适用
An open, prospective, single-arm study investigating safety and efficacy of the human hepatitis B immunoglobulin BT088 after subcutaneous application in liver transplanted patientsClinical Phase: III - STUDY 974PROPHYLAXIS OF HEPATITIS B REINFECTION AFTER LIVER TRANSPLANTATIONMedDRA version: 9.1Level: LLTClassification code 10058827Term: Hepatitis B reactivationEUCTR2008-007625-39-ITBiotest AG130
已完成
不适用
Clinical Trial for Aqua Serum BombCTRI/2022/10/046351Believe Cosmetics Pvt Ltd15
已完成
2 期
Study to evaluate the safety and efficacy of Skin care product for its non comedogenic effectCTRI/2024/01/061563ERIS LIFESCIENCES LTD.20