EUCTR2008-007625-39-IT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 974
适应症
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
- 130
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
- •male and female patients (age 18-75 years)
- •≥ 3 months after liver transplantation
- •HBsAg negative/ HBV-DNA negative in two determinations during the last 3 months
- •after the last i.v. or i.m. administration of HBIg serum HBs antibody concentration between 200 IU/L and 350 IU/L prior to the first dosing of BT088 at day 1
- •regular long-term i.v. or i.m. HBIg prophylaxis (combined re-infection prophylaxis) with stabilised HBIg dosage and administration intervals with i.v. or i.m hepatitis B immunoglobulins
- •stable liver function
- •written informed consent
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •bilirubin ≥ 2 mg /dL, albumin less than 2 g/dL, ascites, protrombin less that 70% , ALAT / ASAT / GGT / AP ≥ 2 times ULN (upper limit of normal )
- •patients who are known to be HBV-DNA positive
- •hepatocarcinoma (hepatocellular carcinoma)
- •positive HIV or HCV test
- •unexplained elevation of liver enzymes
- •ongoing acute rejection episode
- •severe thrombocytopenia or any coagulation disorder that would contraindicate injections
- •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
- •selective absolute Ig A deficiency
- •renal insufficiency (dialysis) or other serious organ dysfunctions
- •life expectancy below 6 months
- •suspicion of drug and / or alcohol abuse
- •inability or lacking motivation to participate in the study
- •participation in another clinical trial within 90 days before entering the study or during the study and/or previous participation in this study
- •the patient planned to be enrolled is an employee of any involved investigator or any involved institution including the sponsor of the trial
研究者
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