Overt Hepatic EncephalopathyNCT06483737
Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)
A study testing Human albumin infusion at a modified dosage, Human albumin infusion at a routine dosage and Lactulose in people with Overt Hepatic Encephalopathy, run by General Hospital of Shenyang Military Region at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overt Hepatic Encephalopathy
- What is being tested?
- Human albumin infusion at a modified dosage, Human albumin infusion at a routine dosage and Lactulose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 1 siteChina
- Study dates
- 24 Jun 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology, General Hospital of Northern Theater Command (formerly called General Hospital of Shenyang Military Area)
Shenyang, Liaoning
Xingshun Qi, 18909881019, xingshunqi@126.com
Qianqian Li, 13940307473, 1208594776@qq.com
About this study
Official title: Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial
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.
Read the 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
- Being tested
- Human albumin infusion at a modified dosage, Human albumin infusion at a routine dosage, Lactulose, Rifaximin, Ornithine Aspartate
- Keywords
- hepatic encephalopathy, liver cirrhosis, human albumin, inflammation, oxidative stress, survival
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human albumin infusion at a modified dosageDrug
Also called AlbuRx
Participants receive intravenous infusion of human albumin at different dosages according to the serum albumin level.
Human albumin infusion at a routine dosageDrug
Also called AlbuRx
Participants receive intravenous infusion of human albumin according to the current clinical practice.
LactuloseDrug
Also called Duphalac
All participants will receive standard treatment of overt HE according to the current practice guideline.
RifaximinDrug
Also called Xifaxan
All participants will receive standard treatment of overt HE according to the current practice guideline.
Ornithine AspartateDrug
All participants will receive standard treatment of overt HE according to the current practice guideline.
Branched-Chain Amino AcidsDrug
Also called Compound amino acid injection
All participants will receive standard treatment of overt HE according to the current practice guideline.
ArginineDrug
Also called Arginine Hydrochloride Injection
All participants will receive standard treatment of overt HE according to the current practice guideline.
| Study group | Role | What they receive |
|---|---|---|
| Modified dosage group | Experimental | Intravenous infusion of human albumin 30-60g. Receives: Drug: Human albumin infusion at a modified dosage; Drug: Lactulose; Drug: Rifaximin; Drug: Ornithine Aspartate; Drug: Branched-Chain Amino Acids; Drug: Arginine |
| Routine dosage group | Active comparator | Intravenous infusion of human albumin 10-20g. Receives: Drug: Human albumin infusion at a routine dosage; Drug: Lactulose; Drug: Rifaximin; Drug: Ornithine Aspartate; Drug: Branched-Chain Amino Acids; Drug: Arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of overt HE.
The change of HE is defined as a decrease or an increase of at least one grade of the West Haven criteria after treatment.
Measured: 3-5 days
Secondary outcomes (4)
Reversal of overt HE.
The reversal of HE is defined as clinical symptoms of overt HE disappear after treatment.
Measured: 3-5 days
Recurrence of overt HE.
Clinical symptoms related to overt HE recur and can be diagnosed with overt HE again according to the West Haven criteria.
Measured: 3 months
Adverse events
Adverse events will be monitored, including allergy, heart failure, pulmonary edema, acute hemolysis, renal dysfunction, and neuropsychiatric abnormalities.
Measured: 3 months
Survival
All participants will be followed by telephone to record survival status, including the major cause and date of death.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start24 Jun 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Overt Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital of Shenyang Military Region
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingshun Qi, General Hospital of Shenyang Military Region
- Investigators
- Xingshun Qi, Principal investigator, Department of Gastroenterology, General Hospital of Northern Theater Command
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483737
- Sponsor's protocol ID
- XHNKKY-OHE-RCT
- Status last verified
- Aug 2025
- First submitted
- 26 Jun 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bai Z, Mendez-Sanchez N, Romeiro FG, Mancuso A, Philips CA, Tacke F, Basaranoglu M, Primignani M, Ibrahim M, Wong YJ, Nery FG, Teschke R, Ferreira CN, Munoz AE, Pinyopornpanish K, Thevenot T, Singh SP, Mohanty A, Satapathy SK, Ridola L, Maruyama H, Cholongitas E, Levi Sandri GB, Yang L, Shalimar, Yang Y, Villa E, Krag A, Wong F, Jalan R, O'Brien A, Bernardi M, Qi X; Liver Cirrhosis-related Complications (LCC)-International Special Interest Group. Use of albumin infusion for cirrhosis-related complications: An international position statement. JHEP Rep. 2023 May 5;5(8):100785. doi: 10.1016/j.jhepr.2023.100785. eCollection 2023 Aug.
PubMed 37456673Sharma BC, Singh J, Srivastava S, Sangam A, Mantri AK, Trehanpati N, Sarin SK. Randomized controlled trial comparing lactulose plus albumin versus lactulose alone for treatment of hepatic encephalopathy. J Gastroenterol Hepatol. 2017 Jun;32(6):1234-1239. doi: 10.1111/jgh.13666.
PubMed 27885712Simon-Talero M, Garcia-Martinez R, Torrens M, Augustin S, Gomez S, Pereira G, Guevara M, Gines P, Soriano G, Roman E, Sanchez-Delgado J, Ferrer R, Nieto JC, Sunye P, Fuentes I, Esteban R, Cordoba J. Effects of intravenous albumin in patients with cirrhosis and episodic hepatic encephalopathy: a randomized double-blind study. J Hepatol. 2013 Dec;59(6):1184-92. doi: 10.1016/j.jhep.2013.07.020. Epub 2013 Jul 19.
PubMed 23872605China L, Freemantle N, Forrest E, Kallis Y, Ryder SD, Wright G, Portal AJ, Becares Salles N, Gilroy DW, O'Brien A; ATTIRE Trial Investigators. A Randomized Trial of Albumin Infusions in Hospitalized Patients with Cirrhosis. N Engl J Med. 2021 Mar 4;384(9):808-817. doi: 10.1056/NEJMoa2022166.
PubMed 33657293Bai Z, Bernardi M, Yoshida EM, Li H, Guo X, Mendez-Sanchez N, Li Y, Wang R, Deng J, Qi X. Albumin infusion may decrease the incidence and severity of overt hepatic encephalopathy in liver cirrhosis. Aging (Albany NY). 2019 Oct 8;11(19):8502-8525. doi: 10.18632/aging.102335. Epub 2019 Oct 8.
PubMed 31596729Li Q, Tong H, Liu X, Liao F, Ma H, Zhou Z, Liu F, Shi H, Wang Z, Sun Y, Yao Q, Feng Y, Li X, Feng J, He Z, Peng Y, Bai Z, Zhu R, Cheng D, Xu C, He S, Yu H, Xie C, Yuan J, Wang X, Yang H, Zou Y, Li S, Li T, Hu S, Chen C, Chen Z, Lantinga MA, Bernardi M, Qi X, Tang C; On the behalf of Young Member Group of Chinese Gastroenterology Society. Human Albumin infusion in liver Cirrhosis and overt Hepatic Encephalopathy (HACHE): protocol of an investigator-initiated, open-label, multicentre, randomised controlled trial. BMJ Open. 2025 Nov 5;15(11):e094300. doi: 10.1136/bmjopen-2024-094300.
PubMed 41198206
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE): an Invesitgator-initiated, Open-label, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06483737
- Acronym / sponsor ID
- XHNKKY-OHE-RCT
- Conditions
- Overt Hepatic Encephalopathy
- Keywords
- hepatic encephalopathy, liver cirrhosis, human albumin, inflammation, oxidative stress, survival
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- General Hospital of Shenyang Military RegionUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified dosage group | Experimental | Drug: Human albumin infusion at a modified dosage, Drug: Lactulose, Drug: Rifaximin, Drug: Ornithine Aspartate, Drug: Branched-Chain Amino Acids, Drug: ArginineIntravenous infusion of human albumin 30-60g. |
| Routine dosage group | Active comparator | Drug: Human albumin infusion at a routine dosage, Drug: Lactulose, Drug: Rifaximin, Drug: Ornithine Aspartate, Drug: Branched-Chain Amino Acids, Drug: ArginineIntravenous infusion of human albumin 10-20g. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Human albumin infusion at a modified dosageAlso: AlbuRxParticipants receive intravenous infusion of human albumin at different dosages according to the serum albumin level. | Drug | Modified dosage group |
| Human albumin infusion at a routine dosageAlso: AlbuRxParticipants receive intravenous infusion of human albumin according to the current clinical practice. | Drug | Routine dosage group |
| LactuloseAlso: DuphalacAll participants will receive standard treatment of overt HE according to the current practice guideline. | Drug | Modified dosage group, Routine dosage group |
| RifaximinAlso: XifaxanAll participants will receive standard treatment of overt HE according to the current practice guideline. | Drug | Modified dosage group, Routine dosage group |
| Ornithine AspartateAll participants will receive standard treatment of overt HE according to the current practice guideline. | Drug | Modified dosage group, Routine dosage group |
| Branched-Chain Amino AcidsAlso: Compound amino acid injectionAll participants will receive standard treatment of overt HE according to the current practice guideline. | Drug | Modified dosage group, Routine dosage group |
| ArginineAlso: Arginine Hydrochloride InjectionAll participants will receive standard treatment of overt HE according to the current practice guideline. | Drug | Modified dosage group, Routine dosage group |
Primary outcome
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.
4 secondary outcomes
Reversal of overt HE.
Time frame: 3-5 days
Recurrence of overt HE.
Time frame: 3 months
Adverse events
Time frame: 3 months
Survival
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Background: PubMed 37456673Bai Z, Mendez-Sanchez N, Romeiro FG, Mancuso A, Philips CA, Tacke F, Basaranoglu M, Primignani M, Ibrahim M, Wong YJ, Nery FG, Teschke R, Ferreira CN, Munoz AE, Pinyopornpanish K, Thevenot T, Singh SP, Mohanty A, Satapathy SK, Ridola L, Maruyama H, Cholongitas E, Levi Sandri GB, Yang L, Shalimar, Yang Y, Villa E, Krag A, Wong F, Jalan R, O'Brien A, Bernardi M, Qi X; Liver Cirrhosis-related Complications (LCC)-International Special Interest Group. Use of albumin infusion for cirrhosis-related complications: An international position statement. JHEP Rep. 2023 May 5;5(8):100785. doi: 10.1016/j.jhepr.2023.100785. eCollection 2023 Aug.
- Results publication: PubMed 27885712Sharma BC, Singh J, Srivastava S, Sangam A, Mantri AK, Trehanpati N, Sarin SK. Randomized controlled trial comparing lactulose plus albumin versus lactulose alone for treatment of hepatic encephalopathy. J Gastroenterol Hepatol. 2017 Jun;32(6):1234-1239. doi: 10.1111/jgh.13666.
- Results publication: PubMed 23872605Simon-Talero M, Garcia-Martinez R, Torrens M, Augustin S, Gomez S, Pereira G, Guevara M, Gines P, Soriano G, Roman E, Sanchez-Delgado J, Ferrer R, Nieto JC, Sunye P, Fuentes I, Esteban R, Cordoba J. Effects of intravenous albumin in patients with cirrhosis and episodic hepatic encephalopathy: a randomized double-blind study. J Hepatol. 2013 Dec;59(6):1184-92. doi: 10.1016/j.jhep.2013.07.020. Epub 2013 Jul 19.
- Results publication: PubMed 33657293China L, Freemantle N, Forrest E, Kallis Y, Ryder SD, Wright G, Portal AJ, Becares Salles N, Gilroy DW, O'Brien A; ATTIRE Trial Investigators. A Randomized Trial of Albumin Infusions in Hospitalized Patients with Cirrhosis. N Engl J Med. 2021 Mar 4;384(9):808-817. doi: 10.1056/NEJMoa2022166.
- Results publication: PubMed 31596729Bai Z, Bernardi M, Yoshida EM, Li H, Guo X, Mendez-Sanchez N, Li Y, Wang R, Deng J, Qi X. Albumin infusion may decrease the incidence and severity of overt hepatic encephalopathy in liver cirrhosis. Aging (Albany NY). 2019 Oct 8;11(19):8502-8525. doi: 10.18632/aging.102335. Epub 2019 Oct 8.
- Derived from this study: PubMed 41198206Li Q, Tong H, Liu X, Liao F, Ma H, Zhou Z, Liu F, Shi H, Wang Z, Sun Y, Yao Q, Feng Y, Li X, Feng J, He Z, Peng Y, Bai Z, Zhu R, Cheng D, Xu C, He S, Yu H, Xie C, Yuan J, Wang X, Yang H, Zou Y, Li S, Li T, Hu S, Chen C, Chen Z, Lantinga MA, Bernardi M, Qi X, Tang C; On the behalf of Young Member Group of Chinese Gastroenterology Society. Human Albumin infusion in liver Cirrhosis and overt Hepatic Encephalopathy (HACHE): protocol of an investigator-initiated, open-label, multicentre, randomised controlled trial. BMJ Open. 2025 Nov 5;15(11):e094300. doi: 10.1136/bmjopen-2024-094300.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xingshun Qi principal investigator
Department of Gastroenterology, General Hospital of Northern Theater Command
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Human albumin infusion at a modified dosage, Human albumin infusion at a routine dosage and Lactulose in people with Overt Hepatic Encephalopathy, run by General Hospital of Shenyang Military Region at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xingshun Qi (18909881019, xingshunqi@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of overt HE. (time frame: 3-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06483737, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025; AzTrials last refreshed its copy on 8 Nov 2026.