What side effects are associated with this type of intervention?

Common treatments for liver cirrhosis, such as diuretics, lactulose, branched-chain amino acids, and nutritional support, have specific side effects. Diuretics can cause electrolyte imbalances and renal dysfunction. Lactulose may lead to gastrointestinal discomfort, including bloating and diarrhea. Branched-chain amino acids are generally well-tolerated but can sometimes cause nausea. Nutritional support, particularly parenteral nutrition, can lead to complications such as infections or metabolic disturbances. IV albumin, used to improve cognitive function by reducing inflammation and endothelial dysfunction, is generally safe but can occasionally cause allergic reactions or fluid overload.

What prior FDA approvals exist?

FDA-approved treatments for liver cirrhosis primarily focus on managing complications and underlying causes. For instance, Tenofovir and Entecavir are approved for patients with cirrhosis due to hepatitis B, aiming to reduce viral load and prevent further liver damage. While IV 25% Albumin is being studied for its potential to improve cognitive function by reducing inflammation and endothelial dysfunction, there are no specific FDA-approved treatments that directly target these mechanisms in cirrhosis. Current standard treatments include diuretics, beta-blockers, and antibiotics to manage symptoms and prevent complications.

What other types of research exist?

Promising alternatives to IV 25% Albumin for liver cirrhosis patients include probiotics and prebiotics, anti-inflammatory agents like TNF inhibitors, bile acid therapies, specific nutritional interventions, and exercise programs. These treatments target inflammation, endothelial dysfunction, and gut microbiota modulation.

← Back to Search

Other

Albumin for Hepatic Encephalopathy (HEAL-LAST Trial)

Phase 2

Recruiting

Research Sponsored by Hunter Holmes Mcguire Veteran Affairs Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >18 years

Be older than 18 years old

Must not have

No prior overt HE

Congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks each

Summary

This trial will test if IV albumin may improve cognitive dysfunction for weeks after treatment in patients with cirrhosis who've had HE & MHE. Biological, cognitive, and HRQOL testing to find out.

Who is the study for?

This trial is for adults over 18 with liver cirrhosis and low platelets, diagnosed through various methods like biopsy or imaging. They must have cognitive impairment from hepatic encephalopathy (HE) but be stable on treatment for at least a month. People with severe HE, unclear diagnosis of cirrhosis, heart failure, recent alcohol abuse, allergies to albumin or infections are excluded.

What is being tested?

The study tests if intravenous albumin can improve brain function in patients with liver cirrhosis who've had HE. Participants receive IV albumin and saline over 8 weeks and serve as their own control while undergoing cognitive tests and health quality assessments.

What are the potential side effects?

While not specified here, common side effects of IV albumin may include allergic reactions such as rash or itching, fever, chills; less commonly it might cause lung problems or changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have never had hepatic encephalopathy.

Select...

I have been diagnosed with congestive heart failure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks each

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks each

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks each for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Delta change in Psychometric Hepatic Encephalopathy Score (PHES) in Placebo phase vs Albumin phase

Secondary study objectives

Change in MELD-Na score Placebo phase vs Albumin phase

Change in PROMIS-29 Placebo phase vs Albumin phase

Change in Sickness Impact Profile Placebo phase vs Albumin phase

+11 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: AlbuminActive Control1 Intervention

IV Albumin at 1.5g/kg ideal body weight

Group II: PlaceboPlacebo Group1 Intervention

Saline given at the same volume as the albumin on visits the patients are assigned to it

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver cirrhosis, such as IV 25% Albumin, work by reducing systemic inflammation, improving endothelial function, and modulating gut microbiota. These mechanisms are vital for liver cirrhosis patients as they help mitigate the disease's progression and associated complications. By addressing these underlying issues, treatments can improve cognitive function, reduce the risk of hepatic encephalopathy, and enhance overall health outcomes.

Parenteral nutrition with branched-chain amino acids in hepatic encephalopathy. A meta-analysis.Novel Anti-inflammatory Treatments in Cirrhosis. A Literature-Based Study.Effects of Albumin Treatment on Systemic and Portal Hemodynamics and Systemic Inflammation in Patients With Decompensated Cirrhosis.