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NCT Number: NCT06483737

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

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.

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Key information

Conditions

Overt Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Inflammation Liver Cirrhosis Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)

Shenyang, Liaoning, China

Location status: Recruiting

Location contact

Qianqian Li

CONTACT

[email protected]

13940307473

Xingshun Qi

CONTACT

[email protected]

18909881019

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Human albumin infusion at a modified dosage

Drug

Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.

Other names: AlbuRx

Human albumin infusion at a routine dosage

Drug

Participants receive intravenous infusion of human albumin according to the current clinical practice.

Other names: AlbuRx

Lactulose

Drug

All participants will receive standard treatment of overt HE according to the current practice guideline.

Other names: Duphalac

Rifaximin

Drug

All participants will receive standard treatment of overt HE according to the current practice guideline.

Other names: Xifaxan

Ornithine Aspartate

Drug

All participants will receive standard treatment of overt HE according to the current practice guideline.

Branched-Chain Amino Acids

Drug

All participants will receive standard treatment of overt HE according to the current practice guideline.

Other names: Compound amino acid injection

Arginine

Drug

All participants will receive standard treatment of overt HE according to the current practice guideline.

Other names: Arginine Hydrochloride Injection

Primary outcomes

  1. Change of overt HE.

    Time frame: 3-5 days

    The change of HE is defined as a decrease or an increase of at least one grade of the West Haven criteria after treatment.

Secondary outcomes

  1. Reversal of overt HE.

    Time frame: 3-5 days

    The reversal of HE is defined as clinical symptoms of overt HE disappear after treatment.

  2. Recurrence of overt HE.

    Time frame: 3 months

    Clinical symptoms related to overt HE recur and can be diagnosed with overt HE again according to the West Haven criteria.

  3. Adverse events

    Time frame: 3 months

    Adverse events will be monitored, including allergy, heart failure, pulmonary edema, acute hemolysis, renal dysfunction, and neuropsychiatric abnormalities.

  4. Survival

    Time frame: 3 months

    All participants will be followed by telephone to record survival status, including the major cause and date of death.

Study contacts

Contact information is provided by the study sponsor or research team.

Qianqian Li

CONTACT

[email protected]

13940307473

Xingshun Qi

CONTACT

[email protected]

18909881019

Sponsors and collaborators

Lead sponsor

General Hospital of Shenyang Military Region

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 3, 2024
Registry last updated
Aug 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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