MedTrace Logo

HEAL STUDY (Hepatic Encephalopathy and Albumin Study)

NCT03585257 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-05-31

No results posted yet for this study

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.

Conditions

  • Cirrhosis
  • Hepatic Encephalopathy
  • Minimal Hepatic Encephalopathy
  • Covert Hepatic Encephalopathy

Interventions

BIOLOGICAL

25% IV albumin

Intravenous 25% albumin infusion 1.0 g/kg body weight (maximum 100gm) once a week for five weeks for a maximum of 5 infusions. These infusions will be administered over sixty minutes per clinical treatment protocols for this population. Patients and investigators will be blinded as to the characteristic of the infusion. Pre-infusion serum albumin will be checked and if \>4.0gm/dl, then normal saline will be given instead as mentioned in the blinding section above. Samples will be collected before and one hour after the infusion for all patients. The total grams of albumin infused over the 4 weeks during and outside the study will be collected and compared between groups.

OTHER

Placebo

Normal saline infusion 1.0g/kg body weight once a week for five weeks for a maximum of 5 infusions. These infusions will be administered over sixty minutes per clinical treatment protocols for this population. Patients and investigators will be blinded as to the characteristic of the infusion. Pre-infusion serum albumin will be checked and if \>4.0gm/dl, then normal saline will be given instead as mentioned in the blinding section above. Samples will be collected before and one hour after the infusion for all patients. The total grams of albumin infused over the 4 weeks during and outside the study will be collected and compared between groups.

Sponsors & Collaborators

  • McGuire Research Institute

    collaborator OTHER

  • Instituto Grifols, S.A.

    collaborator INDUSTRY

  • Hunter Holmes Mcguire Veteran Affairs Medical Center

    lead FED

Principal Investigators

  • Jasmohan Bajaj, MD · Hunter Holmes MVAMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-20
Primary Completion
2022-02-20
Completion
2022-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03585257 on ClinicalTrials.gov