Albumin for Hepatic Encephalopathy

(HEAL-LAST Trial)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Must be taking: Lactulose, Rifaximin

Disqualifiers: Infection, Alcohol abuse, Heart failure, others

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have prior HE controlled by lactulose or rifaximin for at least one month, suggesting you may need to continue these medications.

What evidence supports the effectiveness of the drug albumin for treating hepatic encephalopathy?

Research suggests that human albumin may help reduce the incidence of hepatic encephalopathy (a brain disorder caused by liver disease) and improve outcomes in patients with cirrhosis by addressing inflammation and oxidative stress. However, its effectiveness can vary, as some studies show no significant impact in certain situations, like after specific liver procedures. ^{1 2 3 4 5}

Is albumin safe for use in humans?

Research suggests that albumin is generally safe for use in humans, though some studies have noted potential adverse events like coagulation disorders (problems with blood clotting) in certain cases. More studies are needed to fully understand its safety profile, especially in specific conditions like liver failure. ^{2 3 4 6 7}

How does the drug albumin differ from other treatments for hepatic encephalopathy?

Albumin is unique in treating hepatic encephalopathy because it has anti-inflammatory properties that may help reduce systemic inflammation and oxidative stress, which are believed to contribute to the condition. Unlike other treatments, albumin infusion can improve outcomes in cirrhotic patients by potentially lowering the incidence of hepatic encephalopathy. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Inclusion Criteria

I have been diagnosed with cirrhosis through tests or signs like low platelets or specific liver enzyme ratios.

I have had brain function issues due to liver disease but controlled it with medication for over a month.

You have trouble with your memory and thinking abilities, as shown by specific tests.

Exclusion Criteria

Unlikely to be adherent to the study

I have not had an infection in the last month.

I need or will need albumin infusions regularly.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IV 25% albumin and IV saline over 8 weeks with biological sampling and cognitive and health-related quality of life testing

8 weeks

Weekly visits for infusion and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on cognitive improvement and inflammatory markers

4 weeks

Treatment Details

Interventions

• Albumin (Other)

Trial Overview 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.

Participant Groups

Group I: Albumin Active Control 1 Intervention

IV Albumin at 1.5g/kg ideal body weight

Group II: Placebo Placebo Group 1 Intervention

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

Albumin is already approved in Japan for the following indications:

Approved in Japan as Albumin for:

• Hypoalbuminemia
• Hypovolemia
• Ascites
• Spontaneous Bacterial Peritonitis

Who Is Running the Clinical Trial?

Hunter Holmes Mcguire Veteran Affairs Medical Center

Lead Sponsor

Trials

37

Recruited

21,600+

Grifols Biologicals, LLC

Industry Sponsor

Trials

33

Recruited

9,500+

Findings from Research

In a study of 262 patients with HBV-related decompensated liver cirrhosis, low prealbumin levels were found to be significantly associated with a higher incidence of hepatic encephalopathy (HE).

Prealbumin demonstrated superior diagnostic performance for predicting HE compared to traditional scoring models like MELD and Child-Turcotte-Pugh, with an area under the ROC curve of 0.781.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low Prealbumin Levels Were Associated with Increased Frequency of Hepatic Encephalopathy in Hepatitis B Virus (HBV)-Related Decompensated Cirrhosis. Li, J., Du, M., Li, H., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

No effect of albumin infusion on the prevention of hepatic encephalopathy after transjugular intrahepatic portosystemic shunt. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Low Prealbumin Levels Were Associated with Increased Frequency of Hepatic Encephalopathy in Hepatitis B Virus (HBV)-Related Decompensated Cirrhosis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Albumin therapy for hepatic encephalopathy: current evidence and controversies. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Association of serum albumin level with incidence and mortality of overt hepatic encephalopathy in cirrhosis during hospitalization. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Diagnostic value of albumin-bilirubin grade combined with serum ammonia in cirrhosis with hepatic encephalopathy]. [2018]

6. Spain pubmed.ncbi.nlm.nih.gov

[Artificial liver support. Literature review]. [2018]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy and safety of albumin infusion for overt hepatic encephalopathy: A systematic review and meta-analysis. [2022]