HEAL STUDY (Hepatic Encephalopathy and Albumin Study) (NCT03585257) | Clinical Trial Compass
CompletedPhase 2
HEAL STUDY (Hepatic Encephalopathy and Albumin Study)
United States48 participantsStarted 2018-06-20
Plain-language summary
Patients with continued cognitive impairment after episodes of HE have few options beyond lactulose and rifaximin in the US. Therefore using IV albumin in a randomized, double-blind, placebo-controlled trial, which could beneficially impact inflammation, could be an additional approach to improve cognition.
This 6 week trial will study changes in cognition, HRQOL and inflammation in patients with covert HE after prior overt HE using multiple IV albumin infusions vs. placebo.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age \>18 years
. Cirrhosis defined by any one of the following
. Cirrhosis on liver biopsy or transient wave elastography
. Nodular liver on imaging
. Endoscopic or radiological evidence of varices in a patient with chronic liver disease
. Platelet count \<150,000/mm3 and AST/ALT ratio \>1 in a patient with chronic liver disease
. Patients with frank decompensation (ascites, HE, variceal bleeding, hepato-pulmonary syndrome)
. Prior HE controlled on standard of care therapy defined as lactulose or rifaximin for at least 2 months prior to enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in psychometric hepatic encephalopathy score (PHES) from baseline vs end in albumin vs placebo group
Timeframe: 5 weeks
2
Minimal Hepatic Encephalopathy (MHE) reversal
Timeframe: 5 weeks
Trial details
NCT IDNCT03585257
SponsorHunter Holmes Mcguire Veteran Affairs Medical Center