Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Hu… (NCT03702920) | Clinical Trial Compass
TerminatedPhase 3
Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%
Stopped: Due to corporate business reasons only (non-safety related decision)
United States275 participantsStarted 2019-02-21
Plain-language summary
This is a Phase 3, multicenter, randomized, controlled, parallel-group, open-label study to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects. The study will involve approximately 40 study centers in the United States, Canada, and Europe with expertise in the management of subjects with ACLF.
Subjects with ACLF at a high risk of hospital mortality will be enrolled. The study will consist of a Screening Period during which subjects will be randomized (1:1) to receive either standard medical treatment (SMT) + PE-A 5% (treatment group) or SMT only (control group), followed by a Treatment Period, and a Follow-up Period.
The Treatment Period for subjects in the SMT+ PE-A 5% treatment group will be between 7 and 17 days, depending on ACLF evolution.
The Treatment Period for subjects in the SMT control group will be a minimum of 7 days for all subjects and up to 17 days depending on the ACLF evolution. Subjects in this group will receive SMT according to the institution's standards.
The Follow-up Period for subjects in both groups will be 90 days.
Who can participate
Age range18 Years – 79 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 HE, informed consent will be provided by a relative or a legally authorized representative if the subject is considered incompetent to consent.
Exclusion Criteria:
* Subjects without ACLF.
* Subjects with ACLF-1a or ACLF-3b (See Table 2-1 for ACLF grades) after the Screening Period.
* 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 ACLF for more than 10 days prior to randomization.
* Subjects with acute or subacute liver failure without underlying cirrhosis.
* Subjects with septic shock requiring use of norepinephrine (\> 0.3 mcg/kg/min) or need for a second vasopressor (including terlipressin).
* Subjects with active bacterial or fungal infection: who have received less than 24h of appropriate antibiotic treatment.
* Subjects with severe respiratory failure with PaO2/FiO2 ≤200.
* Subjects with active or recent bleeding (unless controlled…