Who is eligible for clinical trial NCT06052176?

Participants must meet protocol criteria for Cirrhosis. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT06052176 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-08-21

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement (NCT06052176)

🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (13 items).

Location: Hunter Holmes McGuire VA Medical Center — Richmond, Virginia

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

Hunter Holmes McGuire VA Medical Center — Richmond, Virginia

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗