EUCTR2012-002516-51-GB进行中（未招募）1 期
An open, prospective, single arm study investigating efficacy and safety of human 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
- 1 期
- 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
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:
- •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）
不适用
A clinical trial of Zutectra in patients who recently received a livertransplantHepatitis B re-infectionMedDRA version: 15.0Level: LLTClassification code 10058827Term: Hepatitis B reactivationSystem Organ Class: 10021881 - Infections and infestationsEUCTR2012-002516-51-ITBIOTEST 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