Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE) (NCT06483737) | Clinical Trial Compass
RecruitingNot Applicable
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)
China174 participantsStarted 2025-06-24
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of overt HE.
Timeframe: 3-5 days
Trial details
NCT IDNCT06483737
SponsorGeneral Hospital of Shenyang Military Region