Acute-On-Chronic Liver Failure (ACLF) at High Risk of Hospital Mortality

A vizsgálat adatai

Ki végzi

Instituto Grifols S.A.

Azonosító

NCT03702920EU 2022-502187-20-00

A regiszteradat frissítve

2025. január 7.

Eredeti leírás

To evaluate the effect of standard medical treatment (SMT) plus PE-A 5% (SMT+PE-A 5%) on 90-day overall survivalA teljes eredeti leírásKevesebb

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

To evaluate the effect of standard medical treatment (SMT) plus PE-A 5% (SMT+PE-A 5%) on 90-day overall survival

Bevonási feltételek: Male or female cirrhotic subjects between 18 and 79 years of age; 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]); 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; In case of hepatic encephalopathy, informed consent will be provided by a relative or a legally authorized representative if the subject is considered incompetent to consent.

Kizáró feltételek: Subjects with chronic renal failure and currently receiving hemodialysis; Subjects with previous liver transplantation; Participation in another clinical study within at least 30 days prior to screening; Subjects with active drug addiction (exceptions: active alcoholism or marijuana); Subjects with ACLF for more than 10 days prior to randomization; Subjects with active bacterial or fungal infection: who have received less than 24h of appropriate antibiotic treatment; 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, non-melanocytic skin cancer, and controlled breast or prostate cancer can be included); Subjects with severe chronic heart failure (New York Heart Association [NYHA] class III or IV; Subjects with severe pulmonary disease (Global Obstructive Lung Disease [GOLD] stage III or IV); Subjects with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection; 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; Subjects with acute or subacute liver failure without underlying cirrhosis; Subjects with severe respiratory failure with PaO2/FiO2 ≤200; Subjects with active or recent bleeding (unless controlled for >48 hours); Subjects with severe thrombocytopenia (≤20×109/L) (based on local laboratory assessment); Subjects receiving anti-platelet or anti-coagulant therapy (low molecular weight heparin [LMWH] for deep vein thrombosis [DVT] prophylaxis is allowed); Subjects without ACLF; Subjects with severe myopathy as defined clinically; 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); Subjects with ACLF-1a or ACLF-3b after the Screening Period; Subjects with a do-not-resuscitate order; In the opinion of the investigator, the subject may have compliance problems with the protocol and the procedures of the protocol; 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); Subjects with septic shock requiring use of norepinephrine (> 0.3 mcg/kg/min) or need for a second vasopressor (including terlipressin).

ClinicalTrials.gov NCT03702920 · EU CTIS 2022-502187-20-00