Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Cirrhosis, Hepatic Encephalopathy

In brief

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.

Key facts

Study ID

NCT06052176

Run by

Hunter Holmes Mcguire Veteran Affairs Medical Center

People needed

30

Starts

2023-11-02

Expected to finish

2026-12-01

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age >18 years
• Cirrhosis diagnosed using either (a) liver biopsy, (b) transient wave elastography (>20 KPa) (c) radiological evidence consistent with cirrhosis, (d) in a patient with chronic liver disease endoscopic or radiological evidence of varices (e), in a patient with chronic liver disease, platelet count <150,000/mm3 and AST/ALT ratio >1.
• Cognitive impairment defined by MHE on psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF), or EncephalApp Stroop
• Prior HE controlled by lactulose or rifaximin for at least one month
• Serum albumin <4gm/dl

You may not qualify if…

• Unclear diagnosis of cirrhosis
• No prior overt HE
• No cognitive impairment on the tests noted
• Requiring regular albumin infusions within 3 months or anticipated during the study visit
• Infection within a month
• Allergies to albumin
• Unlikely to be adherent to the study
• Unable or unwilling to consent
• West Haven Criteria>2
• Alcohol abuse within 1 month
• Serum albumin >4gm/dl
• Congestive heart failure

Where it is running

• Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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