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
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- PROPHYLAXIS OF HEPATITIS B REINFECTION AFTER LIVER TRANSPLANTATION
- 发起方
- Biotest AG
- 入组人数
- 130
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •\&\#61485;male and female patients (age 18\-75 years)
- •\&\#61485;\&\#8805; 3 months after liver transplantation
- •\&\#61485;HBsAg negative/ HBV\-DNA negative in two determinations during the last 3 months
- •\&\#61485;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
- •\&\#61485;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
- •\&\#61485;stable liver function
- •\&\#61485;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
排除标准
- •\&\#61485;bilirubin \&\#8805; 2 mg /dL, albumin less than 2 g/dL, ascites, protrombin less that 70% , ALAT / ASAT / GGT / AP \&\#8805; 2 times ULN (upper limit of normal )
- •\&\#61485;patients who are known to be HBV\-DNA positive
- •\&\#61485;hepatocarcinoma (hepatocellular carcinoma)
- •\&\#61485;positive HIV or HCV test
- •\&\#61485;unexplained elevation of liver enzymes
- •\&\#61485;ongoing acute rejection episode
- •\&\#61485;severe thrombocytopenia or any coagulation disorder that would contraindicate injections
- •\&\#61485;pregnancy or unreliable contraceptive measures or lactation period (females only)
- •\&\#61485;known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction)
- •\&\#61485;known intolerance to proteins of human origin
结局指标
主要结局
未指定
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