EUCTR2005-005987-94-DE进行中（未招募）不适用
Double-blind placebo-controlled randomised trial of lamivudine in the treatment of acute hepatitis B - GAHB-Study
niversity of Leipzig0 个研究点目标入组 140 人开始时间: 2006年4月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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
- •- Acute hepatitis
- •- HBsAg positive
- •- Compensated liver function (Quick > 50%)
- •- Bilirubin > 5mg/dl (i.e. >85µmol/l)
- •- ALAT > 10 times upper normal range
- •- Age >= 18 years
- •- Time since diagnosis < 8 days
- •- Written informed consent of the patient
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Known or obvious pre-existing liver disease (by e.g. spider naevis, ascites)
- •- Ongoing interferon therapy or stop of interferon less than 3 months ago
- •- Ongoing drug abuse
- •- HIV positive
- •- Anti-HCV or HCV-RNA positive
- •- Anti-HDV positive
- •- Renal insufficiency (creatinine >1.5mg/dl or 135µmol/l)
- •- Pregnant or nursing women
- •- Women with child bearing potential (< 2 years after last menstruation) without
- •effective contraception
- •- Use of oral contraception
- •- Patient with transplanted organs
- •- Any disease requiring immunosuppressive therapy, incl. cancer chemotherapy
- •- Any acute infectious disease requires administration of sulphonamide/ trimethoprim
- •- Evidence of any other disease, metabolic dysfunction, physical examination finding,
- •or clinical laboratory finding giving reasonable suspicion of a disease or condition
- •that contraindicates use of an investigational drug, or patient at high risk from
- •treatment complications
- •- Known hypersensitivity to any of the study drugs or its ingredients
- •- Current or recent (within 30 days prior to start of trial treatment) treatment with
- •another investigational drug or participation in another investigational trial
- •- Expected low compliance (e.g. by travel distance to trial site)
研究者
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