EUCTR2011-004394-90-AT进行中（未招募）不适用
Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - IM1 - KLH in CHC – IM1
Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Gastroenterologie und Hepatologie0 个研究点开始时间: 2011年12月12日最近更新:
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
- •- CHC of any Genotype
- •- compensated liver cirrhosis (Child Pugh A or Child Pugh B, 7 points)
- •- presence of at least one contraindication against standard therapy (Peginterferon alpha 2a/b and Ribavirin)
- •Contraindications are:
- •- hypersensitivity against Peginterferon alpha 2a/b and Ribavirin
- •- severe heart disease
- •- liver cirrhosis of Child Pugh =6
- •- hemoglobinopathias
- •- platelet count Thrombozytenzahl < 90000/mm 3
- •- neutrophil count absolute < 1500/mm 3
- •- psychosis, depression
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •1)hypersensitivity against KLH
- •2)immunosuppression (therapy with steroids, Azathioprin, Mycophenolat, TNF alpha blockers, calcineurin inhibitors, IL2 blockers)
- •3)hepatocellular carcinoma
- •4)coinfektion with hepatitis B and / or HIV
- •5)pregnancy
- •6)cardiovascular event (stroke, myocardial infarction) during the last 6 months
- •7)uncontrolled diabetes (HbA1c > 10)
- •8)chronic renal insufficiency (GFR < 50 ml/min) or chronic hemodialysis
研究者
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