Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06052176

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Led by Hunter Holmes Mcguire Veteran Affairs Medical Center · Updated on 2026-04-08

30

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

Sponsors

H

Hunter Holmes Mcguire Veteran Affairs Medical Center

Lead Sponsor

G

Grifols Biologicals, LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age >18 years
  • Cirrhosis diagnosed by liver biopsy, transient wave elastography (>20 KPa), radiological evidence, endoscopic or radiological evidence of varices in chronic liver disease, or platelet count <150,000/mm3 with AST/ALT ratio >1 in chronic liver disease
  • Cognitive impairment defined by minimal hepatic encephalopathy on psychometric hepatic encephalopathy score, critical flicker frequency, or EncephalApp Stroop test
  • Prior overt hepatic encephalopathy controlled by lactulose or rifaximin for at least one month
  • Serum albumin level less than 4 gm/dl
Not Eligible

You will not qualify if you...

  • Unclear diagnosis of cirrhosis
  • No prior overt hepatic encephalopathy
  • No cognitive impairment on specified tests
  • Requiring regular albumin infusions within 3 months or anticipated during the study
  • Infection within one month
  • Allergies to albumin
  • Unlikely to be adherent to the study
  • Unable or unwilling to consent
  • West Haven Criteria greater than 2
  • Alcohol abuse within one month
  • Serum albumin level greater than 4 gm/dl
  • Congestive heart failure

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, United States, 23249

Actively Recruiting

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Research Team

J

Jasmohan Bajaj, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

PREVENTION

Number of Arms

2

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