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CirrhosisPhase 2HEAL-LASTNCT06052176

Hepatic Encephalopathy and Albumin Lasting Cognitive Improvement

A Phase 2 study testing Albumin Infusion in people with Cirrhosis and Hepatic Encephalopathy, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cirrhosis, Hepatic Encephalopathy
What is being tested?
Albumin Infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteUnited States
Study dates
2 Nov 2023to 1 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hunter Holmes McGuire VA Medical Center

    Richmond, Virginia, 23249

Other trials in United States

About this study

Official title: Randomized Clinical Trial in Hepatic Encephalopathy to Study Lasting Cognitive Improvement With Intravenous Albumin

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.

Read the detailed description

In outpatients with cirrhosis with prior HE who have cognitive impairment despite adequate therapy, how long the impact of albumin lasts and through which potential mechanism(s) needs to be determined.

A prior recent HEAL trial showed that patients with prior HE and current minimal hepatic encephalopathy (MHE) randomized to albumin experienced significant improvement in cognitive dysfunction and psychosocial quality of life. Moreover, these improvements persisted a week after the last albumin infusion, which was not seen in the placebo group. This was accompanied by an improvement in endothelial dysfunction, ischemia-modified albumin levels and inflammatory markers that persisted one week even after albumin discontinuation. The reported half-life of IV albumin is 2 weeks, but the function and the length of time of albumin's action in decompensated cirrhosis is lower, and further details surrounding albumin pharmacokinetics in this population remain unelucidated. The mechanisms and length of time albumin's potential improvement for patients with MHE after treatment discontinuation also require continued study.

Study design:

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.

Th order of the albumin and placebo infusion and blind the infusions from the subjects and the assessors of the outcomes will be changed.

Being tested
Albumin Infusion
Keywords
albumin, cirrhosis, inflammation, cognitive performance
Medical subject headings
Fibrosis, Hepatic Encephalopathy, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Albumin InfusionDrug

    Also called Albutein

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

Study groups in NCT06052176
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSaline given at the same volume as the albumin on visits the patients are assigned to it
Receives: Drug: Albumin Infusion
AlbuminActive comparatorIV Albumin at 1.5g/kg ideal body weight
Receives: Drug: Albumin Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 weeks each

Secondary outcomes (14)

  1. EncephalApp Stroop change in Placebo phase vs Albumin phase

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

    Measured: 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

    Measured: 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)

    Measured: 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)

    Measured: 4 weeks each

  5. Change in MELD-Na score Placebo phase vs Albumin phase

    Liver disease severity change using MELD-Na; higher is worse

    Measured: 4 weeks each

  6. Change in endotoxin binding protein Placebo phase vs Albumin phase

    Change in endotoxin binding protein will be recorded in the serum; higher is worse

    Measured: 4 weeks each

  7. Change in oxidized albumin Placebo phase vs Albumin phase

    Change in oxidized albumin will be recorded in the serum ; higher is worse

    Measured: 4 weeks each

  8. Change in ischemia modified albumin Placebo phase vs Albumin phase

    Change in ischemia modified albumin will be recorded in the serum

    Measured: 4 weeks each

  9. Change in stool bile acids Placebo phase vs Albumin phase

    Change in stool bile acids (total, primary, secondary, conjugated/deconjugated) will be recorded

    Measured: 4 weeks each

  10. Change in serum bile acids Placebo phase vs Albumin phase

    Change in serum bile acids (total, primary, secondary, conjugated/deconjugated) will be recorded

    Measured: 4 weeks each

  11. Change in serum Short-chain fatty acids Placebo phase vs Albumin phase

    Change in serum Short-chain fatty acids (acetate, propionate, butyrate will be recorded

    Measured: 4 weeks each

  12. Change in stool Short-chain fatty acids Placebo phase vs Albumin phase

    Change in stool Short-chain fatty acids (acetate, propionate, butyrate will be recorded

    Measured: 4 weeks each

  13. Change in stool bacterial alpha diversity Placebo phase vs Albumin phase

    Change in Shannon diversity of stool bacteria

    Measured: 4 weeks each

  14. Change in serum inflammatory cytokines Placebo phase vs Albumin phase

    Change in IL-6, TNF-α, IL-10, IL-1β in serum

    Measured: 4 weeks each

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2023
  2. Study start2 Nov 2023
  3. Primary completion1 Oct 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06052176
Sponsor's protocol ID
BAJAJ0035
Acronym
HEAL-LAST
Status last verified
Aug 2026
First submitted
18 Sep 2023
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Albumin Infusion in people with Cirrhosis and Hepatic Encephalopathy, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Delta change in Psychometric Hepatic Encephalopathy Score (PHES) in Placebo phase vs Albumin phase (time frame: 4 weeks each). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06052176.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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