EUCTR2007-001744-53-DE进行中（未招募）不适用
Open, randomized 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 - passive-active immunization
niversity of Leipzig0 个研究点开始时间: 2008年2月4日最近更新:
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相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •no adequate reponse to a previous triple sole active Hepatitis B vaccination (anti-HBs Titer <100 IU/ml)
- •written informed consent for participation in the study
- •age 18-65 years
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •HBsAg positive
- •Anti-HCV positive
- •Anti-HIV positive
- •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
- •Known or obvious pre-existing liver disease (e.g. M. Wilson, hemochromatosis, autoimmune hepatitis, Hepatitis C). These diseases are clinical relevant renal, cardiac, pulmonary, vascular or metabolic (disease of thyroid, adrenal disease) diseases, an immune compromised status or malignant diseases
- •Intake of hepatotoxic agents (e.g. Aminoglycoside, Amphotericin B, Vancomycin, Cidofovir, Foscarnet, Cisplatin, Pentamidin, Tacrolimus, Cyclosporin). Foreseeable necessity or intention for taking these therapeutics within the last two months prior to screening or at inclusion.
- •Intake of nephrotoxic agents (e.g. anabolic steroids, Ketokonazol, Itrakonazol, Isoniazid, Rifampicin, Rifabutin, Statine). Foreseeable necessity or intention for taking these therapeutics within the last two months prior to screening or at inclusion.
- •Treatment with immunoglobulins, Interferon or other immunologic or cytokines-based therapy concepts with possible impact on a hepatitis B infection. Foreseeable necessity or intention for taking these therapeutics within the last six months prior to screening or at inclusion.
- •Treatment with steroids, immunosuppressives or chemotherapeutic agents. Foreseeable necessity or intention for taking these therapeutics within the last two months prior to screening or at inclusion.
- •subject with known thromophilic disease and/or previous thromboembolic events in the anamnesis
- •Organ- or bone marrow engrafted subjects
- •Concomitant participation in other clinical trials or treatment with another investigational drug within the last 2 months prior to screening
- •planned vaccination outside the vaccination for the trial during at inclusion (e.g. vaccination of influenza)
- •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
- •Allergic reactions to other vaccinations or immunoglobulins in anamnesis
- •Women during pregnancy und lactation
- •Women with child bearing potential (< 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)
研究者
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