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

Instituto Grifols S.A.0 个研究点目标入组 380 人开始时间: 2019年1月2日最近更新: 2022年8月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Instituto Grifols S.A.
入组人数: 380

研究概览入排标准研究者记录与标识符相似试验

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. 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.
•6v3. Subjects with septic shock requiring use of norepinephrine (> 0.3 mcg/kg/min) need for a second vasopressor (including terlipressin).
•7v3. Subjects with active bacterial or fungal infection : who have received less than 24h of appropriate antibiotic treatment.
•8v3. Subjects with severe respiratory failure with PaO2/FiO2 =200.
•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.
•19v3. Subjects receiving anti-platelet or anti-coagulant therapy (low-molecular-weight heparin [LMWH] for deep vein thrombosis [DVT] prophylaxis is allowed).
•20. Participation in another clinical study within at least 30 days prior to screening.
•21v3. Subjects with active drug addiction (exceptions: active alcoholism or marijuana)
•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.
•24. Subjects with current infection of COVID19, those who are less than 14 days post recovery or those who have clinical signs and symptoms consistent with COVID19 infection.

研究者

发起方

Instituto Grifols S.A.

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