Health TrialsbyHealthPanel

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

ConditionsCirrhosisHepatic Encephalopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunter Holmes Mcguire Veteran Affairs Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Albumin Infusion

    Drug

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: AlbuminActive comparator 1 intervention

Trial outcomes

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

Time frame
4 weeks each

Secondary outcomes

1

EncephalApp Stroop change in Placebo phase vs Albumin phase

cognitive improvement (Stroop OffTime+OnTime in seconds will be evaluated); higher is worse

Time frame
4 weeks each
2

Critical Flicker Frequency change in Placebo phase vs Albumin phase

cognitive improvement (Hz at which CFF is reached will be evaluated), higher is good

Time frame
4 weeks each
3

Change in Sickness Impact Profile Placebo phase vs Albumin phase

Health-related quality of life change (SIP total, psychosocial and physical scores where a higher score indicates poor HRQOL willl be evaluated)

Time frame
4 weeks each
4

Change in PROMIS-29 Placebo phase vs Albumin phase

Health-related quality of life change (Total PROMIS-29 score will be evaluated)

Time frame
4 weeks each

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunter Holmes Mcguire Veteran Affairs Medical Center

Lead sponsor

Grifols Biologicals, LLC

Collaborator

Source ClinicalTrials.gov
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