NCT06483737

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: General Hospital of Shenyang Military Region · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hepatic encephalopathy (HE), a severe complication of decompensated cirrhosis, is characterized as neurocognitive dysfunction. Emerging evidence suggests the potential role of human albumin infusion for the treatment of HE, but its optimal dosage remains undefined. Therefore, the investigators planned a randomized controlled trial (RCT) to compare the efficacy of human albumin infusion at different dosages in in patients with liver cirrhosis and overt HE.

Detailed description

Overall, 174 patients with a diagnosis of liver cirrhosis, overt HE, and a serum albumin level of 23-30g/L will be enrolled. They will be stratified according to the severity of overt HE and randomly assigned at a ratio of 1:1 into the groups of human albumin infusion at a modified dosage and a routine dosage. The primary endpoint is the improvement of overt HE within 3-5 days after treatment. The secondary endpoints include recurrence of overt HE, survival, and adverse events.

Conditions

• Overt Hepatic Encephalopathy

Interventions

Type	Name	Description
DRUG	Human albumin infusion at a modified dosage	Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.
DRUG	Human albumin infusion at a routine dosage	Participants receive intravenous infusion of human albumin according to the current clinical practice.
DRUG	Lactulose	All participants will receive standard treatment of overt HE according to the current practice guideline.
DRUG	Rifaximin	All participants will receive standard treatment of overt HE according to the current practice guideline.
DRUG	Ornithine Aspartate	All participants will receive standard treatment of overt HE according to the current practice guideline.
DRUG	Branched-Chain Amino Acids	All participants will receive standard treatment of overt HE according to the current practice guideline.
DRUG	Arginine	All participants will receive standard treatment of overt HE according to the current practice guideline.

Timeline

• Start date: 2025-06-24
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-07-03
• Last updated: 2025-08-26

Locations

1 site across 1 country: China