Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Study ID
NCT06052176
Phase
PHASE2
Status
Recruiting
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Conditions

  • Cirrhosis
  • Hepatic Encephalopathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Albumin Infusion — DRUG
    Intravenous human serum albumin to be given at 1.5g/kg ideal body weight

Study Details

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.

Key Dates

Start date
Nov 2, 2023
Status verified
Apr 2026
Primary completion
Oct 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Placebo
    Saline given at the same volume as the albumin on visits the patients are assigned to it
  • Active Comparator: Albumin
    IV Albumin at 1.5g/kg ideal body weight

Primary Outcome Measure

Delta change in Psychometric Hepatic Encephalopathy Score (PHES) in Placebo phase vs Albumin phase [ Time Frame: 4 weeks each ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hunter Holmes McGuire VA Medical CenterRichmondVirginia23249
Haley Obolewicz, RN
[email protected]
804 675 5000
Travis Mousel, RN
[email protected]
804 675 5584
Jasmohan S Bajaj, MD, MSc (PRINCIPAL_INVESTIGATOR)

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Hunter Holmes McGuire VA Medical Center· Richmond, VA

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