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Albumin Infusion

25% IV albumin for Encephalopathy (HEAL Trial)

Phase 2
Waitlist Available
Led By Jasmohan Bajaj, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks

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.

Eligible Conditions
  • Encephalopathy
  • Hepatic Encephalopathy
  • Liver Cirrhosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Improvement in psychometric hepatic encephalopathy score (PHES) from baseline vs end in albumin vs placebo group
Minimal Hepatic Encephalopathy (MHE) reversal
Secondary study objectives
Change in Critical Flicker Frequency (CFF) results in Hz from baseline vs end in albumin vs placebo group
Change in EncephalApp Stroop OffTime+OnTime in seconds from baseline vs end in albumin vs placebo group
Change in SIckness Impact Profile (SIP) Questionnaire results from baseline vs end in albumin vs placebo group
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IV albuminExperimental Treatment1 Intervention
25% IV albutein (albumin) formulation will be infused 1.0g/kg IV over one hour weekly for 5 weeks
Group II: PlaceboPlacebo Group1 Intervention
Normal saline will be infused 1.0g/kg IV over one hour weekly for 5 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
25% IV albumin
2018
Completed Phase 2
~50

Find a Location

Who is running the clinical trial?

Instituto Grifols, S.A.Industry Sponsor
29 Previous Clinical Trials
5,379 Total Patients Enrolled
Hunter Holmes Mcguire Veteran Affairs Medical CenterLead Sponsor
36 Previous Clinical Trials
21,558 Total Patients Enrolled
McGuire Research InstituteOTHER
9 Previous Clinical Trials
333 Total Patients Enrolled
~7 spots leftby Oct 2025
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