Overview

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Status:
Recruiting
Trial end date:
2025-06-01
Target enrollment:
Participant gender:
Summary
Hypothesis: Improvement in cognitive dysfunction with IV albumin in patients with cirrhosis with prior HE and MHE lasts for several weeks after albumin infusion has ended, and is due to persistent improvement in inflammatory markers, endothelial dysfunction, albumin function and gut microbial changes. This will be a single-arm, single-blind sequential trial of IV 25% albumin and IV saline over 8 weeks with biological sampling and cognitive and health related quality of life (HRQOL) testing with each subject acting as their own control.
Phase:
Phase 2
Details
Lead Sponsor:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Collaborator:
Grifols Biologicals, LLC