DRKS00013775招募中不适用
Adjuvant therapy of severe and/or refractory bullous pemphigoids with immunoadsorption by LIGASORB®, dapsone, prednisolone and topical mometasone fumarate (LiBPem-Study). - LiBPem
niversitätsklinikum Schleswig-Holstein Campus Lübeck0 个研究点目标入组 10 人开始时间: 2018年5月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Patiens with diagnostically confirmed BP (direct immunofluorescence, proof of IgG-reactivity against PB180 in ELISA)
- •- Age >= 18 years of Age
- •- written informed consent
- •- > 30 % of Body surface area with BP-lesions OR
- •- refractive therapy to conventional immunosuppression / immunomodulation according to the Guidelines of the German Dermatology Society (Deutsche Dermatologische Gesellschaft (Eming et al., j Dtsch Dermatol Ges 2015))
排除标准
- •- proven oversensitivity against materials and/or medications used in the study (see allergy pass)
- •- severe coagulopathy
- •- severe cardiovascular disease (NYHA IV, myocardial infarction within the last 3 months)
- •- intake of ACE-Inhibitors
- •- women of child-bearing age who do not use adequate birth control methods
- •- severe systemic infection (HBsAg-positive chronic active Hepatitis B, Hepatitis C, HIV-infection, florid TBC-infection, acute viral infections (e.g., variella, Zoster Virus, severe HSV-1 infection)
- •- pregnant or lactating women
- •- severe congenital immune deficiency
- •- florid gastro-duodenal ulcer
- •- active, progressive malignomas, or malignomas which are currently treated with chemo- / immunotherapy. Patients with malignomas in complete Remission have to consult an oncologist Prior to study enrollment
- •-severe liver and kidney dysfunction (>= 3 times elevated serum-GOT, >= 3 times elevated Serum creatinine
- •- Hb < 9g/dl or leukopenia < 3000/microliter or thrombocytopenia < 100.000/mircoliter with reduced bone marrow function
- •- acute or unstable psychiatric diseases with high risk of exacerbation with intake of high-dose prednisolone
- •- written informed consent not possible
- •- inadequte knowledge of the German language or illiteracy (questionnaires have to be filled out by the study Patients themselves)
- •- concurrent participation in another clinical trial
研究者
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