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Could a simple protein infusion boost brain function in liver disease?

NCT ID NCT06052176

Disease control Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times

Summary

This study looks at whether giving a protein called albumin through a vein can help improve thinking and memory in people with liver cirrhosis who have had episodes of confusion (hepatic encephalopathy). The trial will involve 30 participants who will receive both albumin and a placebo (saline) at different times, acting as their own control. Researchers will measure changes in cognitive tests and quality of life to see if the benefits last even after treatment ends.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Started

Nov 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 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 * Congestive heart failure

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Conditions

The condition(s) this trial relates to.

cirrhosis of liver Fibrosis hepatic encephalopathy Inflammation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cirrhosis Hepatic encephalopathy

Contacts and locations

Locations

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.