EUCTR2016-001787-10-FR进行中（未招募）1 期
Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects with Acute-On-Chronic Liver Failure (ACLF) at High Risk of Hospital Mortality - APACHE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 380
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
入选标准
- •1. Male or female cirrhotic subjects between 18 and 79 years of age.
- •2. Subjects with ACLF-1b, ACLF-2, or ACLF-3a detected either at admission or during
- •hospitalization (must be ACLF-1b, -2, or -3a within the Screening Period [a maximum of
- •10 days]) (see Table 2-1 for ACLF grades in the study protocol).
- •3. Willing and able to provide written informed consent or have an authorized
- •representative able to provide written informed consent on behalf of the subject in
- •accordance with local law and institutional policy.
- •4. In case of HE, informed consent will be provided by a relative or a legally authorized
- •representative (surrogate).
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 80
排除标准
- •1. Subjects without ACLF.
- •2. Subjects with ACLF-1a or ACLF-3b (see Table 2-1 for ACLF grades in the study protocol) after the Screening
- •3. Subjects fulfilling inclusion criteria that improve to no ACLF or to ACLF-1a or worsen
- •to ACLF-3b during the Screening Period (between initial evaluation and time of randomization).
- •4. Subjects with ACLF for more than 10 days prior to randomization.
- •5. Subjects with acute or subacute liver failure without underlying cirrhosis.
- •6. Subjects with septic shock lasting >1 hour that does not respond to fluid resuscitation-IV
- •therapy or pharmacologic-pressors.
- •7. Subjects with active bacterial or fungal infection with hemodynamic instability.
- •8. Subjects with acute respiratory distress syndrome with peripheral oxygen saturation (SpO2) =89.
- •9. Subjects with active or recent bleeding (unless controlled for >48 hours).
- •10. Subjects with severe thrombocytopenia (=20×109/L) (based on local laboratory assessment).
- •11. Subjects with chronic renal failure and currently receiving hemodialysis.
- •12. Evidence of current locally advanced or metastatic malignancy. Subjects with hepatocellular carcinoma within the Milan criteria (1 nodule =5 cm or 3 nodules =3 cm [Appendix 5 of the study protocol]), non-melanocytic skin cancer, and controlled breast or prostate cancer can be included).
- •13. Subjects with severe chronic heart failure (New York Heart Association [NYHA] class III or IV) (Appendix 6 of the study protocol).
- •14. Subjects with severe pulmonary disease (Global Obstructive Lung Disease [GOLD] stage III or IV) (Appendix 7 of the study protocol).
- •15. Subjects with severe myopathy as defined clinically.
- •16. Subjects with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.
- •17. Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence*) throughout the study.
- •* True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception).
- •18. Subjects with previous liver transplantation.
- •19. Subjects receiving anti-platelet or anti-coagulant therapy.
- •20. Participation in another clinical study within at least 30 days prior to screening.
- •21. Subjects with active drug addiction.
- •22. Subjects with a do-not-resuscitate order.
- •23. In the opinion of the investigator, the subject may have compliance problems with the
- •protocol and the procedures of the protocol.
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