Acute-On-Chronic Liver FailureNCT06377774
To Optimize Therapeutic Procedures of DPMAS in ACLF Patients: a Prospective, Sigle Arm and Multicenter Study
An observational study of Acute-On-Chronic Liver Failure, run by Nanfang Hospital, Southern Medical University.
Trial summary
Acute-on-chronic liver failure (ACLF) is a life-threaten syndrome carrying high-short-term mortality raging 40% to 60% within 90 days in patients with chronic liver disease. Double plasma molecular adsorption system (DPMAS) is one of the available artificial liver support systems, which combines plasma filtration and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- How many people
- 2,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Feb 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study focus on acute-on-chronic liver failure (ACLF) patients which carries high prevalence and short-term mortality. ACLF patients are featured by multiple organ failure. Except for liver transplantation, the routine use of artificial or bioartifical extracorporeal liver support or plasma exchange appears to be a promising and effective bridging therapy in patients with ACLF to liver transplantation or spontaneous regeneration.
Who may be able to join
- Sign the informed consent voluntarily;
- Age>18 years old;
- Inpatients;
- Chronic liver disease;
- The value of total bilirubin≥12mg/dl and INR≥1.5;
- Patients are planned to have DPMAS therapy according to the physicians' judgment.
Who cannot join
- The pregnant;
- With severe chronic heart disease (NYHA>II);
- With severe chronic obstructive pulmonary disease (GOLD>III);
- With serious mental illness that prevents patients from sell-reporting;
- Patients with unstable hemodynamics caused by infection or acute bleeding;
- Diagnosis of hepatocellular carcinoma during screening period (BCLC>B);
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- With severe extrahepatic malignant carcinoma;
- Patients who had liver resection or other organ transplantation;
- Patients who had participated in, or are planning to participate in other clinical trial within the 3 months prior to enrollment;
- Hospital stays <48 hours;
- Not suitable to participate in this study judging by researchers;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: To Optimize Therapeutic Procedures of Double-plasma Molecular Absorption System Therapy in acute-on Chronic Liver Failure Patients: a Prospective, Sigle Arm and Multicenter Study
Acute-on-chronic liver failure (ACLF) is a life-threaten syndrome carrying high-short-term mortality raging 40% to 60% within 90 days in patients with chronic liver disease. Double plasma molecular adsorption system (DPMAS) is one of the available artificial liver support systems, which combines plasma filtration and two specific adsorption membranes dedicating to remove bilirubin and the middle molecular toxins respectively. The efficiency of DMPAS treatment in liver failure patients remains controversial. Previous study indicate that liver failure patients with DPMAS therapy improve the short-term mortality and prevent the diseases progression within 28 days (PADSTONE Study). Thus, this single-arm, multicenter and prospective study is to further validate and optimize the therapeutic procedures of DPMAS therapy in ACLF patients.
Read the detailed description
Liver failure in patients with chronic liver disease (CLD) and carries high short-term mortality ranging 40% to 60% within 90 days. In China Mainland, chronic hepatitis B virus (HBV) infection is the most common etiology of liver failure in CLD patients which reveals histological signature with submissive hepatic necrosis. While liver transplantation (LT) remains the treatment of choice, the lack of organ transplants necessitates finding alternative solutions. Supportive therapy including cardiovascular or renal support, treatment of encephalopathy and extracorporeal liver support, are the available treatments for liver failure patients in the clinical practice.
Artificial liver support system (ALSS) can remove inflammatory cytokines and toxins which is commonly used in clinical practice to treat liver failure. Double plasma molecular adsorption system (DPMAS) which is one of the ALSS combines plasma filtration and two specific adsorption membranes which can effectively remove bilirubin and the middle molecular toxins respectively. Within the last years, DPMAS is developed to one of the most recent non-biological extracorporeal liver support devices that used in acute or acute-on-chronic liver failure (ACLF) patients. In the clinical practice, DPMAS therapy in liver failure patients usually combines with therapeutic plasma exchange (PE). Previous investigations suggested that DPMAS and therapeutic PE were similar in improving 90-day survivals and DPMAS together with PE ameliorated the inflammatory response and improved the 28-day survival in HBV related ACLF.
However, the efficiency of DMPAS treatment in liver failure patients remains controversial and no large scale study to explore the potential subgroup of liver failure patients with chronic liver disease that may benefit from DPMAS therapy at present. Our previous study (PADSTONE Study) indicate that DPMAS therapy may improve the short-term mortality and prevent the disease progression in ACLF patients which needs to be further validated.
Accordingly, this single-arm study will enroll the ACLF patients with DPMAS therapy and aim to optimize and validate the therapeutic procedures of the DPMAS therapy in ACLF patients. Biological-samples will be collected in this study including plasma, urine and stools and multi-omics will be performed to explore and validate the precise profiles/biomarkers of the indication of DPMAS treatment.
- Conditions
- Acute-On-Chronic Liver Failure
- Being tested
- No intervention in this study
- Keywords
- double plasma molecular adsorption system, acute-on-chronic liver failure, short-term mortality
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention in this studyOther
No intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| DPMAS therapy group | This is a prosepctive, sigle-arm and muticenter study. The study will enroll ACLF patients which receive the DPMAS therpay during hospitalization. Receives: Other: No intervention in this study |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day transplantation-free mortality
Comparing to the PADSTONE study, the 28-day transplantation-free mortality in ACLF patients with DPMAS therapy.
Measured: 28 days
The disease progression rate
Comparing to the PADSTONE study, the disease progression (progress to EASL defined ACLF) rate within 28 days.
Measured: 28 days
Secondary outcomes (2)
the 90-day transplantation-free mortality
Comparing to the PADSTONE study, the 90-day transplantation-free mortality in ACLF patients with DPMAS therapy.
Measured: 90 days
the disease progression
Comparing to the PADSTONE study, the disease progression (progress to EASL defined ACLF) rate within 90 days
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jinjun Chen, Dr., Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377774
- Sponsor's protocol ID
- NFEC-2024-096
- Status last verified
- Apr 2024
- First submitted
- 14 Apr 2024
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Optimize Therapeutic Procedures of Double-plasma Molecular Absorption System Therapy in acute-on Chronic Liver Failure Patients: a Prospective, Sigle Arm and Multicenter Study
- ClinicalTrials.gov ID
- NCT06377774
- Acronym / sponsor ID
- NFEC-2024-096
- Conditions
- Acute-On-Chronic Liver Failure
- Keywords
- double plasma molecular adsorption system, acute-on-chronic liver failure, short-term mortality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 22 Apr 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.
Acute-on-chronic liver failure (ACLF) is a life-threaten syndrome carrying high-short-term mortality raging 40% to 60% within 90 days in patients with chronic liver disease. Double plasma molecular adsorption system (DPMAS) is one of the available artificial liver support systems, which combines plasma filtration and two specific adsorption membranes dedicating to remove bilirubin and the middle molecular toxins respectively. The efficiency of DMPAS treatment in liver failure patients remains controversial. Previous study indicate that liver failure patients with DPMAS therapy improve the short-term mortality and prevent the diseases progression within 28 days (PADSTONE Study). Thus, this single-arm, multicenter and prospective study is to further validate and optimize the therapeutic procedures of DPMAS therapy in ACLF patients.
Detailed description
Liver failure in patients with chronic liver disease (CLD) and carries high short-term mortality ranging 40% to 60% within 90 days. In China Mainland, chronic hepatitis B virus (HBV) infection is the most common etiology of liver failure in CLD patients which reveals histological signature with submissive hepatic necrosis. While liver transplantation (LT) remains the treatment of choice, the lack of organ transplants necessitates finding alternative solutions. Supportive therapy including cardiovascular or renal support, treatment of encephalopathy and extracorporeal liver support, are the available treatments for liver failure patients in the clinical practice.
Artificial liver support system (ALSS) can remove inflammatory cytokines and toxins which is commonly used in clinical practice to treat liver failure. Double plasma molecular adsorption system (DPMAS) which is one of the ALSS combines plasma filtration and two specific adsorption membranes which can effectively remove bilirubin and the middle molecular toxins respectively. Within the last years, DPMAS is developed to one of the most recent non-biological extracorporeal liver support devices that used in acute or acute-on-chronic liver failure (ACLF) patients. In the clinical practice, DPMAS therapy in liver failure patients usually combines with therapeutic plasma exchange (PE). Previous investigations suggested that DPMAS and therapeutic PE were similar in improving 90-day survivals and DPMAS together with PE ameliorated the inflammatory response and improved the 28-day survival in HBV related ACLF.
However, the efficiency of DMPAS treatment in liver failure patients remains controversial and no large scale study to explore the potential subgroup of liver failure patients with chronic liver disease that may benefit from DPMAS therapy at present. Our previous study (PADSTONE Study) indicate that DPMAS therapy may improve the short-term mortality and prevent the disease progression in ACLF patients which needs to be further validated.
Accordingly, this single-arm study will enroll the ACLF patients with DPMAS therapy and aim to optimize and validate the therapeutic procedures of the DPMAS therapy in ACLF patients. Biological-samples will be collected in this study including plasma, urine and stools and multi-omics will be performed to explore and validate the precise profiles/biomarkers of the indication of DPMAS treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DPMAS therapy group | – | Other: No intervention in this studyThis is a prosepctive, sigle-arm and muticenter study. The study will enroll ACLF patients which receive the DPMAS therpay during hospitalization. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study focus on acute-on-chronic liver failure (ACLF) patients which carries high prevalence and short-term mortality. ACLF patients are featured by multiple organ failure. Except for liver transplantation, the routine use of artificial or bioartifical extracorporeal liver support or plasma exchange appears to be a promising and effective bridging therapy in patients with ACLF to liver transplantation or spontaneous regeneration.
Key inclusion criteria (6 listed)
- Sign the informed consent voluntarily;
- Age>18 years old;
- Inpatients;
- Chronic liver disease;
- The value of total bilirubin≥12mg/dl and INR≥1.5;
Key exclusion criteria (11 listed)
- The pregnant;
- With severe chronic heart disease (NYHA>II);
- With severe chronic obstructive pulmonary disease (GOLD>III);
- With serious mental illness that prevents patients from sell-reporting;
- Patients with unstable hemodynamics caused by infection or acute bleeding;
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 |
|---|---|---|
| No intervention in this studyNo intervention in this study | Other | DPMAS therapy group |
Primary outcome
28-day transplantation-free mortality
Time frame: 28 days
Comparing to the PADSTONE study, the 28-day transplantation-free mortality in ACLF patients with DPMAS therapy.
The disease progression rate
Time frame: 28 days
Comparing to the PADSTONE study, the disease progression (progress to EASL defined ACLF) rate within 28 days.
2 secondary outcomes
the 90-day transplantation-free mortality
Time frame: 90 days
the disease progression
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Acute-On-Chronic Liver Failure
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Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
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Very Low-volume Plasma Exchange in ACLF
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A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
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. This study is not recruiting at the moment.
Jinjun Chen, Dr. principal investigator
Nanfang Hospital, Southern Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute-On-Chronic Liver Failure, run by Nanfang Hospital, Southern Medical University.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Beiling Li, Dr (+8613570541527, 820584791@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day transplantation-free mortality (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2024.