An observational study in Acute-on-Chronic Liver Failure (ACLF), sponsored by The Second Affiliated Hospital of Chongqing Medical University. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by The Second Affiliated Hospital of Chongqing Medical University · Observational
Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →
Among 48 studies in Acute-On-Chronic Liver Failure with a site in China — 18 open to participants now, 22 under way, none of them phase 3. Acute-On-Chronic Liver Failure · China.
Among the 48 studies in Acute-On-Chronic Liver Failure with a site in China, this one is the 13th largest by planned enrollment of the 23 observational ones that give a count, is one of 3 that started in 2026, is one of 23 observational ones, reaches primary completion later than 21 of the 21 other live ones, and was the 48th registered.
167 studies on the registry are indexed under Acute-On-Chronic Liver Failure; 62 are open to participants now.
Browse Acute-On-Chronic Liver Failure studies →18 of the 48 studies in Acute-On-Chronic Liver Failure with a site in China are open now. Recruiting first, the newest first:
Shenzhen Third People's Hospital · Sites in China
Ages 18–75
Sun Yat-sen University · Sites in China
Ages 18+
Third Affiliated Hospital, Sun Yat-Sen University · Sites in China
Ages 18–70
RenJi Hospital · Sites in China
Ages 18–65
Nanfang Hospital, Southern Medical University · Sites in China
Ages 18–80
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 32 Acute-On-Chronic Liver Failure studies recruiting now, 11 (34%) set no upper age limit and 15 (47%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 18 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
48 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 9 · Phase 2 8 · Phase 4 1
First in 2007; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400 is above the median of 235 across 65 observational studies indexed under Acute-On-Chronic Liver Failure.
Median enrollment 80 across the 25 interventional studies, 411 across the 23 observational. Of the 11 that completed or were terminated, 1 (9%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 48 have an industry lead sponsor. The 10 most frequent:
The Second Affiliated Hospital of Chongqing Medical University is the lead sponsor of 103 studies on the registry; 33 are open to participants now.
The Second Affiliated Hospital of Chongqing Medical University has 1 study filed under Acute-On-Chronic Liver Failure — fewer than ten, so there is no comparison to draw.
5 of the studies in Acute-On-Chronic Liver Failure with a site in China that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05985863Beijing 302 HospitalHuman Umbilical Cord Mesenchymal Stem Cell Transplantation for The Treatment of Acute-on-Chronic Liver Failure | 2026-12-30 |
| NCT06996392Third Affiliated Hospital, Sun Yat-Sen UniversityPhase I Trial of QH-1A Hybrid Bio-Artificial Liver With Ex Vivo Blood-Purifying MSCs in Acute-on-Chronic Liver Failure | 2026-12-31 |
| NCT07409259Third Affiliated Hospital, Sun Yat-Sen UniversityPT-MSCs Exosome Injection in the Treatment of Chronic-to-acute Liver Failure | 2027-08-31 |
| NCT06562803Third Affiliated Hospital, Sun Yat-Sen UniversityEfficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis | 2027-10-31 |
| NCT06916585Shenzhen Third People's HospitalChinese Phase II Trail of AS1501 in Acute-on-chronic Liver Failure (ACLF) Patients | 2027-11-30 |
Add all 5 to your calendar (.ics) → With an account.
Among the 48 studies in Acute-On-Chronic Liver Failure with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study compares two blood-filtering treatment approaches used in adults with acute-on-chronic liver failure, a sudden worsening of liver function in people with long-term liver disease.
Both approaches include plasma exchange, which removes and replaces the liquid part of the blood. One approach combines plasma exchange with a system that uses filters to remove certain substances from the blood. The other combines plasma exchange with continuous kidney support therapy, which helps remove waste and excess fluid.
The treating doctors and patients decide which treatment to use as part of routine care. The study does not assign treatment. The researchers will follow participants to find out how many are alive without a liver transplant 90 days after joining the study. They will also compare complications, blood test results, and safety outcomes. Participants may choose to join a separate part of the study that collects blood and stool samples.
This multicenter, prospective, observational cohort study uses a noninferiority design to compare two artificial liver support strategies in adults with acute-on-chronic liver failure: plasma exchange plus double plasma molecular adsorption system (PE plus DPMAS) and plasma exchange plus continuous renal replacement therapy (PE plus CRRT).
The planned enrollment is 400 participants across two hospitals, with a target of 200 participants in each cohort. Treatment decisions are made in routine clinical practice by the treating clinicians in consultation with patients. Participants are grouped according to the treatment they receive. The study protocol does not assign treatment, and there is no randomization.
The primary outcome is 90-day transplant-free survival, measured from enrollment. The first occurrence of death from any cause or liver transplantation is counted as an event. An independent committee blinded to treatment group adjudicates the primary outcome events. The analysis will use propensity score matching to address measured differences between the two cohorts.
An optional exploratory substudy plans to enroll 120 consenting participants. Research blood samples will be used for peripheral blood mononuclear cell single-cell RNA sequencing and plasma-based omics analyses. Stool samples will be used to characterize the gut microbiome. Participants may decline the substudy and still participate in the main cohort.
The study population consists of adults aged 18 to 80 years with acute-on-chronic liver failure who are scheduled to receive artificial liver support for the first time at one of two participating hospitals in China. Eligible patients who provide written informed consent are enrolled prospectively. The two cohorts are defined by the treatment received in routine clinical care: plasma exchange plus double plasma molecular adsorption system (PE plus DPMAS) or plasma exchange plus continuous renal replacement therapy (PE plus CRRT). The study protocol does not assign treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adults with acute-on-chronic liver failure who receive plasma exchange (PE) in combination with the double plasma molecular adsorption system (DPMAS) as part of routine clinical care. The study protocol does not assign treatment.
Adults with acute-on-chronic liver failure who receive plasma exchange (PE) in combination with continuous renal replacement therapy (CRRT) as part of routine clinical care. The study protocol does not assign treatment.
90-Day Transplant-Free Survival
The percentage of participants who are alive and have not undergone liver transplantation at Day 90 after enrollment. Death from any cause or liver transplantation is counted as an event, whichever occurs first.
Time frame: From enrollment through Day 90
28-Day Transplant-Free Survival
The percentage of participants who are alive and have not undergone liver transplantation at Day 28 after enrollment. Death from any cause or liver transplantation is counted as an event, whichever occurs first.
Time frame: From enrollment through Day 28
Occurrence of Liver Transplantation
The percentage of participants who undergo liver transplantation during follow-up. The date of transplantation is recorded.
Time frame: From enrollment through Day 90
Change in Hepatic Encephalopathy Grade
Change in West Haven hepatic encephalopathy grade from baseline at each follow-up assessment, categorized as improvement, no change, or worsening.
Time frame: Baseline and Day 28, Day 90, Week 24, and Week 48 after enrollment
Reversal of Hepatorenal Syndrome
Percentage of participants with hepatorenal syndrome at baseline who meet the prespecified criteria for reversal at each follow-up assessment. Hepatorenal syndrome is diagnosed according to the International Club of Ascites criteria specified in the study protocol.
Time frame: Baseline and Day 28, Day 90, Week 24, and Week 48 after enrollment
Correction of Hyponatremia
Percentage of participants with hyponatremia at baseline who meet the prespecified correction criterion at each follow-up assessment, based on serum sodium measurements.
Time frame: Baseline and Day 28, Day 90, Week 24, and Week 48 after enrollment
Correction of Hyperkalemia
Percentage of participants with hyperkalemia at baseline who meet the prespecified correction criterion at each follow-up assessment, based on serum potassium measurements.
Time frame: Baseline and Day 28, Day 90, Week 24, and Week 48 after enrollment
Change From Baseline in SOFA Score
Change in the Sequential Organ Failure Assessment (SOFA) score from baseline at each follow-up assessment. The total score ranges from 0 to 24, with higher scores indicating more severe organ dysfunction.
Time frame: Baseline and Day 28, Day 90, Week 24, and Week 48 after enrollment
Relative Change in Total Bilirubin From Baseline During Serial Treatment and Follow-up
elative change in total bilirubin from baseline at each subsequent treatment-related and follow-up assessment, using the prespecified calculation method. Treatment-related measurements are obtained within 48 hours before the start and within 48 hours after the end of each artificial liver support session. Both increases and decreases are recorded.
Time frame: Baseline; within 48 hours before the start and after the end of each artificial liver support session; and Day 28, Day 90, Week 24, and Week 48 after enrollment
Change in Blood Ammonia From Baseline
Change in blood ammonia concentration from baseline at each postbaseline assessment, reported in micromoles per liter (μmol/L). Measurements are obtained within 48 hours before the start and within 48 hours after the end of each artificial liver support session, and at the scheduled follow-up assessments.
Time frame: Baseline; within 48 hours before the start and after the end of each artificial liver support session; and Day 28, Day 90, Week 24, and Week 48 after enrollment
Change in Serum Creatinine From Baseline
Change in serum creatinine concentration from baseline at each postbaseline assessment, reported in micromoles per liter (μmol/L). Measurements are obtained within 48 hours before the start and within 48 hours after the end of each artificial liver support session, and at the scheduled follow-up assessments.
Time frame: Baseline; within 48 hours before the start and after the end of each artificial liver support session; and Day 28, Day 90, Week 24, and Week 48 after enrollment
Change in INR From Baseline
Change in the international normalized ratio (INR) from baseline at each postbaseline assessment. Measurements are obtained within 48 hours before the start and within 48 hours after the end of each artificial liver support session, and at the scheduled follow-up assessments.
Time frame: Baseline; within 48 hours before the start and after the end of each artificial liver support session; and Day 28, Day 90, Week 24, and Week 48 after enrollment
Plan to share: No — There is no plan to share individual participant data with researchers outside the study team. Aggregate results may be reported in publications.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jun 2028, 19 months later.
Of 38 observational studies under Acute-On-Chronic Liver Failure, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 19 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Acute-On-Chronic Liver Failure →
The Second Affiliated Hospital of Chongqing Medical University →