ISRCTN84821453已完成2 期
Open randomised study for evaluation of an active hepatitis B vaccination (HBVAXPRO) in combination with a passive immunisation with hepatitis B immunoglobulins (Hepatect) for subjects who did not show any or an adequate reaction to a previous sole active hepatitis B immunisation
niversity of Leipzig (Germany)0 个研究点目标入组 8 人开始时间: 2008年10月9日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. No adequate response to a previous triple sole active hepatitis B vaccination (anti-HBs titre less than 100 IU/ml)
- •2. Written informed consent for participation in the study
- •3. Aged 18 to 65 years, either sex
排除标准
- •1. Hepatitis B surface antigen (HBsAg) positive
- •2. Anti-hepatitis C virus (Anti-HCV) positive
- •3. Anti-human immunodeficiency virus (Anti-HIV) positive
- •4. Any serious or active physical or psychological disease which has an impact on the treatment option or the compliance of the subject by estimation of investigator
- •5. Known or obvious pre-existing liver disease (e.g., M. Wilson, haemochromatosis, autoimmune hepatitis, hepatitis C). These diseases are clinically relevant renal, cardiac, pulmonary, vascular or metabolic (disease of thyroid, adrenal disease) diseases, an immune compromised status or malignant diseases
- •6. Intake of hepatotoxic agents (e.g. aminoglycoside, amphotericin B, vancomycin, cidofovir, foscarnet, cisplatin, pentamidin, tacrolimus, cyclosporin), or a foreseeable necessity or intention for taking these therapeutics within the last two months prior to screening or at inclusion
- •7. Intake of nephrotoxic agents (e.g. anabolic steroids, ketokonazol, itrakonazol, isoniazid, rifampicin, rifabutin, statine), or a foreseeable necessity or intention for taking of these therapeutics within the last two months prior to screening or at inclusion
- •8. Treatment with immunoglobulins, interferon or other immunologic or cytokines-based therapy concepts with possible impact on a hepatitis B infection, or a foreseeable necessity or intention for taking these therapeutics within the last six months prior to screening or at inclusion
- •9. Treatment with steroids, immunosuppressives or chemotherapeutic agents, or a foreseeable necessity or intention for taking these therapeutics within the last two months prior to screening or at inclusion
- •10. Subjects with known thrombophilic disease and/or previous thromboembolic events in the anamnesis
- •11. Organ or bone marrow engrafted subjects
- •12. Concomitant participation in other clinical trials or treatment with another investigational drug within the last 2 months prior to screening
- •13. Planned vaccination outside the vaccination for the trial during the whole study time (e.g. vaccination of influenza)
- •14. Ongoing alcohol or drug abuse which has an impact on the compliance of the subject, the result of the vaccination during the whole study time or the evaluation of adverse events
- •15. Allergic reaction to vaccinations or immunoglobulins in anamnesis
- •16. Women during pregnancy and lactation
- •17. Women with child bearing potential (less than 2 years after the last menstruation) without effective contraception (implants, injections, oral contraception, intrauterine devices - spirals etc., partner with vasectomy) during the trial (subjects who takes a hormonal method of contraception will be informed about possible effects of the study medication)
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