Human albumin for overt hepatic encephalopathy in liver cirrhosis
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 174 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | General Hospital of Shenyang Military Region Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT06483737 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shenyang, Liaoning
- 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 participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.