Human albumin for overt hepatic encephalopathy in liver cirrhosis
Official title: Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial
Run by General Hospital of Shenyang Military Region · NCT06483737 · Data updated 2026-11-12
This research will test whether different doses of human albumin help adults with liver cirrhosis and overt hepatic encephalopathy regain mental function sooner.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 174 (estimated) |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Status | Recruiting |
| Started | June 24, 2025 |
| Main results expected | June 30, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | August 26, 2025 |
| Trial ID | NCT06483737 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with diagnosed liver cirrhosis, overt hepatic encephalopathy, serum albumin 23–30 g/L, and the ability to provide informed consent are the intended participants.
✕Probably not a fit
Patients with contraindications to albumin, acute liver failure, prior TIPS, severe cardiac or pulmonary disease, psychiatric or neurologic disorders, or who are pregnant or lactating are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial will enroll 174 adults with liver cirrhosis, overt hepatic encephalopathy, and serum albumin between 23–30 g/L. Participants will be stratified by HE severity and randomized 1:1 to receive either a modified-dose or a routine-dose regimen of human albumin alongside standard HE care (lactulose, rifaximin, and ornithine aspartate as needed). The primary outcome is improvement of overt HE within 3–5 days after treatment, and secondary outcomes include HE recurrence, survival, and adverse events. The single-center study is conducted at the Department of Gastroenterology, General Hospital of Northern Theater Command in Shenyang, China.
Why it matters
Potential benefit: If successful, optimizing albumin dosing could speed recovery from overt HE, reduce recurrences, and potentially improve survival in patients with cirrhosis.
How similar studies have gone: Some prior studies and observational data suggest albumin can improve outcomes in cirrhosis and HE, but randomized comparisons of different dosing regimens are limited, making this dosing comparison relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * A definite diagnosis of liver cirrhosis and overt HE * A serum albumin level of 23-30g/L * Age ≥18 years old * Sign the informed consent Exclusion Criteria: * Contraindications to human albumin infusion * A history of transjugular intrahepatic portosystemic shunt * A diagnosis of acute liver failure * Severe heart and/or lung diseases * Psychiatric or nervous diseases * Pregnant or lactating
Where it's running
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Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning, China Recruiting
Study contacts
- Principal investigator: Xingshun Qi — Department of Gastroenterology, General Hospital of Northern Theater Command
- Study coordinator: Xingshun Qi
- Email: xingshunqi@126.com
- Phone: 18909881019
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.