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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks each

Awards & highlights

HEAL-LAST Trial 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.Check my eligibility

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.See study design

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.

HEAL-LAST Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am older than 18 years.

HEAL-LAST Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

HEAL-LAST 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hunter Holmes Mcguire Veteran Affairs Medical CenterLead Sponsor

35 Previous Clinical Trials

21,521 Total Patients Enrolled

9 Trials studying Liver Cirrhosis

405 Patients Enrolled for Liver Cirrhosis

Grifols Biologicals, LLCIndustry Sponsor

32 Previous Clinical Trials

9,426 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any danger in administering Albumin to patients?

"Our team at Power rated Albumin's safety a 2, as this phase two trial has some evidence of its safety but no data affirming efficacy."

Answered by AI

Are there any available openings for patients to join this trial?

"At the moment, this medical trial is not recruiting patients. The clinicaltrials.gov posted initially on October 1st 2023 and was last edited 18th September 2023. However, there are 591 other studies actively searching for volunteers right now."

Answered by AI