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 range18 Years
SexALL
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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.
Exclusion criteria
✕. Unclear diagnosis of cirrhosis (does not meet the criteria outlined above)
✕. No prior overt HE episodes
✕. HE uncontrolled on standard of care defined as a mini-mental status exam\<25
✕. On regular IV albumin infusions due to scheduled paracentesis within the last 3 months
✕. Recent alcohol abuse (within 3 months)
✕
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