EUCTR2008-000730-42-FR进行中（未招募）1 期
An open-label, multi-centre, clinical study to collect information on the clinical use of argatroban in patients with heparin induced thrombocytopenia (HIT) Type II who require parenteral antithrombotic therapy. - ARG-E07
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •1. Subjects aged = 18 years
- •2. Females of child bearing potential must have a negative urine pregnancy test prior to entry into the study
- •3. Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral anticoagulation
- •4. Signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative
- •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
- •1. Uncontrolled bleeding
- •2. Severe hepatic impairment (Child-Pugh Class C)
- •3. Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol)
- •4. Pregnancy (exclusion by routine urine test)
- •5. Lactating woman
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