Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

NCT06052176 | Recruiting Phase 2 FDA Drug

• 1 other identifier: BAJAJ0035
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis; Hepatic Encephalopathy

Keywords

albumin; cirrhosis; inflammation; cognitive performance

Outcome Measures

Primary Outcomes (1)

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

  cognitive improvement (PHES score ranges from -15 to 5), higher is good

  4 weeks each

Secondary Outcomes (14)

• EncephalApp Stroop change in Placebo phase vs Albumin phase

  4 weeks each

• Critical Flicker Frequency change in Placebo phase vs Albumin phase

  4 weeks each

• Change in Sickness Impact Profile Placebo phase vs Albumin phase

  4 weeks each

• Change in PROMIS-29 Placebo phase vs Albumin phase

  4 weeks each

• Change in MELD-Na score Placebo phase vs Albumin phase

  4 weeks each

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline given at the same volume as the albumin on visits the patients are assigned to it

Drug: Albumin Infusion

Albumin

ACTIVE COMPARATOR

IV Albumin at 1.5g/kg ideal body weight

Drug: Albumin Infusion

Interventions

Albumin Infusion DRUG

Intravenous human serum albumin to be given at 1.5g/kg ideal body weight

Also known as: Albutein

Albumin; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Cirrhosis diagnosed using either (a) liver biopsy, (b) transient wave elastography (\>20 KPa) (c) radiological evidence consistent with cirrhosis, (d) in a patient with chronic liver disease endoscopic or radiological evidence of varices (e), in a patient with chronic liver disease, platelet count \<150,000/mm3 and AST/ALT ratio \>1.
• Cognitive impairment defined by MHE on psychometric hepatic encephalopathy score (PHES), critical flicker frequency (CFF), or EncephalApp Stroop
• Prior HE controlled by lactulose or rifaximin for at least one month
• Serum albumin \<4gm/dl

You may not qualify if:

• Unclear diagnosis of cirrhosis
• No prior overt HE
• No cognitive impairment on the tests noted
• Requiring regular albumin infusions within 3 months or anticipated during the study visit
• Infection within a month
• Allergies to albumin
• Unlikely to be adherent to the study
• Unable or unwilling to consent
• West Haven Criteria\>2
• Alcohol abuse within 1 month
• Serum albumin \>4gm/dl
• Congestive heart failure

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead
• Grifols Biologicals, LLC: collaborator

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

RECRUITING

MeSH Terms

Conditions

Fibrosis; Hepatic Encephalopathy; Inflammation

Interventions

Albumins

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins

Central Study Contacts

Jasmohan Bajaj, MD

CONTACT

8046755802; jasmohan.bajaj@vcuhealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be blinded to which infusions are albumin versus placebo. All infusion tubing and bag will be covered in foil and the subjects will not be aware of the timing of the saline vs albumin infusion to maintain blinding for the patient.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2023
• First Posted: September 25, 2023
• Study Start: November 2, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)