EUCTR2009-015403-95-CZ进行中（未招募）1 期
A pilot trial of noninvasive assessment of methotrexate hepatotoxicity in the course of pharmacokinetically guided pharmacotherapy of psoriasis with methotrexate and folic acid
Faculty Hospital Hradec Králové0 个研究点目标入组 90 人开始时间: 2009年10月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
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
- •- patients with moderate-severe or severe psoriasis requiring systemic immunosuppressive therapy
- •- patients had never received MTX or had not been taking MTX for at least 6 months preceding the study
- •- results of the laboratory tests without clinically significant alterations: Blood count (Hb, Hct, erythrocytes, leukocytes, differential blood count, platelets), Liver tests (ALT, AST, AP, g GT, albumin bilirubin), Creatinine/Urea, Urine sediment
- •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
- •Desire to have children (for both men and women)
- •Pregnancy and nursing
- •Inadequate contraception
- •Drug abuse
- •Alcoholism
- •Known sensitivity to active ingredient methotrexate (e.g. pulmonary toxicity)
- •Dysfunction of the bone marrow
- •Severe liver disease
- •Severe infections
- •Immunodeficiency
- •Active peptic ulcer
- •Hematologic changes (leukopenia, thrombocytopenia, anemia)
- •Renal failure
研究者
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