Acute-On-Chronic Liver FailureNCT05030571
The Effects of Double Plasma Molecular Adsorption System in Acute on Chronic Liver Failure Patients
A study testing DPMAS and standard treatment in people with Acute-On-Chronic Liver Failure and Acute on Chronic Hepatic Failure, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Acute liver failure patients posed high mortality rate despite receiving standard therapy. The severity and mortality even higher in patients with underlying liver disease. Acute liver failure cause hyperinflammatory response in early stage and immunoparalysis in later stage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute-On-Chronic Liver Failure, Acute on Chronic Hepatic Failure
- What is being tested?
- DPMAS and standard treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2021to 1 Apr 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
- Age 18 or more
- Diagnosis of Acute ontop chronic liver failure by Asian Pacific association for the study of the liver (APASL) criteria
- Admitted to intensive care unit
Who cannot join
- Pregnancy
- Received steroid treatment
- Expected dead within 24 hour
- WBC < 500/mm3
- Allergy to DPMAS
- History of organ transplant
- Terminal illness with do not resuscitation order
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Bangkok
Sasipha Tachaboon
About this study
Acute liver failure patients posed high mortality rate despite receiving standard therapy. The severity and mortality even higher in patients with underlying liver disease. Acute liver failure cause hyperinflammatory response in early stage and immunoparalysis in later stage. The surge of proinflammatory cytokines leads to multiorgan failure and more liver injury. Subsequent immunoparalysis may lead to lethal secondary infections.
Liver support system had been used in acute and acute ontop chronic liver disease for last several decades. Double plasma molecular adsorption system (DPMAS) is one of the promising non-biological liver support system that have been extensively investigated in acute ontop chronic liver failure from hepatits B viral. DPMAS circuit consist of BS330 (bilirubin adsorber) and HA330 (Cytokines adsorber). Thus, DPMAS can also remove various cytokines. The effect of DPMAS on immune function in these patients has not been explored.
Read more
Recent randomized controlled trial by Srisawat et al. demonstrated improvement of mHLA-DR in septic shock patients who received polymyxin B extracorporeal therapy compare to control arm. Since liver failure show change of immunological profile resemble to sepsis. Investigators proposed that removal of toxic liver toxins and lethal cytokines by DPMAS will improve immunological profiles in acute ontop chronic liver failure patients.
Investigators plan to conduct a randomized controlled trial in acute ontop chronic liver failure patients who admitted to intensive care unit. Investigators plan to compare the immunomodulatory effects of DPMAS with standard treatments.
- Being tested
- DPMAS, standard treatment
- Keywords
- Hemoperfusion, Acute-On-Chronic Liver Failure, Cytokine adsorbant therapy, HA-330
- 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.
DPMASDevice
DPMAS circuit consist of Plasmaflo OP cartridge (Asahi Medical, Tokyo, Japan), Ion exchange resin hemoperfusion cartridge (BS330; Jafron, Zhuhai City, China), and Neutral adsorption resin hemoperfusion cartridge (HA330-II; Jafron, Zhuhai City, China)
standard treatmentOther
standard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group will receive DPMAS extracorporeal treatment one session per day for 3 consecutive days plus standard therapy. We plan to use blood flow rate of 100-120 ml/hour with filtration fraction for plasma separation of 25-30%. DPMAS circuit consist of Plasmaflo OP cartridge (Asahi Medical, Tokyo, Japan), Ion exchange resin hemoperfusion cartridge (BS330; Jafron, Zhuhai City, China), and Neutral adsorption resin hemoperfusion cartridge (HA330-II; Jafron, Zhuhai City, China) We do not use any anticoagulant. Receives: Device: DPMAS; Other: standard treatment |
| Standard care | Active comparator | Standard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017 Receives: Other: standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
mHLA-DR expression
mHLA-DR expression
Measured: 7 days
Secondary outcomes (5)
survival rate
survival rate
Measured: 28 days
Reduction of total bilirubin
Reduction of total bilirubin
Measured: 7 days
hepatic encephalopathy grading
hepatic encephalopathy grading
Measured: 28 days
subsequent bacterial infection
subsequent bacterial infection
Measured: 28 days
CD11b expression
CD11b expression
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Jan 2021
- Primary completion1 Jan 2025
- Study completion1 Apr 2027 (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 Chulalongkorn 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Srisawat ,M.D., Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030571
- Sponsor's protocol ID
- IRB.216/64
- Status last verified
- Jun 2026
- First submitted
- 26 Aug 2021
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Double Plasma Molecular Adsorption System in Acute on Chronic Liver Failure Patients
- ClinicalTrials.gov ID
- NCT05030571
- Acronym / sponsor ID
- IRB.216/64
- Keywords
- Hemoperfusion, Acute-On-Chronic Liver Failure, Cytokine adsorbant therapy, HA-330
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 1 Sep 2021 (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 liver failure patients posed high mortality rate despite receiving standard therapy. The severity and mortality even higher in patients with underlying liver disease. Acute liver failure cause hyperinflammatory response in early stage and immunoparalysis in later stage. The surge of proinflammatory cytokines leads to multiorgan failure and more liver injury. Subsequent immunoparalysis may lead to lethal secondary infections.
Liver support system had been used in acute and acute ontop chronic liver disease for last several decades. Double plasma molecular adsorption system (DPMAS) is one of the promising non-biological liver support system that have been extensively investigated in acute ontop chronic liver failure from hepatits B viral. DPMAS circuit consist of BS330 (bilirubin adsorber) and HA330 (Cytokines adsorber). Thus, DPMAS can also remove various cytokines. The effect of DPMAS on immune function in these patients has not been explored.
Recent randomized controlled trial by Srisawat et al. demonstrated improvement of mHLA-DR in septic shock patients who received polymyxin B extracorporeal therapy compare to control arm. Since liver failure show change of immunological profile resemble to sepsis. Investigators proposed that removal of toxic liver toxins and lethal cytokines by DPMAS will improve immunological profiles in acute ontop chronic liver failure patients.
Investigators plan to conduct a randomized controlled trial in acute ontop chronic liver failure patients who admitted to intensive care unit. Investigators plan to compare the immunomodulatory effects of DPMAS with standard treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: DPMAS, Other: standard treatmentIntervention group will receive DPMAS extracorporeal treatment one session per day for 3 consecutive days plus standard therapy. We plan to use blood flow rate of 100-120 ml/hour with filtration fraction for plasma separation of 25-30%. DPMAS circuit consist of Plasmaflo OP cartridge (Asahi Medical, Tokyo, Japan), Ion exchange resin hemoperfusion cartridge (BS330; Jafron, Zhuhai City, China), and Neutral adsorption resin hemoperfusion cartridge (HA330-II; Jafron, Zhuhai City, China) We do not use any anticoagulant. |
| Standard care | Active comparator | Other: standard treatmentStandard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or more
- Diagnosis of Acute ontop chronic liver failure by Asian Pacific association for the study of the liver (APASL) criteria
- Admitted to intensive care unit
Key exclusion criteria (7 listed)
- Pregnancy
- Received steroid treatment
- Expected dead within 24 hour
- WBC < 500/mm3
- Allergy to DPMAS
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 |
|---|---|---|
| DPMASDPMAS circuit consist of Plasmaflo OP cartridge (Asahi Medical, Tokyo, Japan), Ion exchange resin hemoperfusion cartridge (BS330; Jafron, Zhuhai City, China), and Neutral adsorption resin hemoperfusion cartridge (HA330-II; Jafron, Zhuhai City, China) | Device | Intervention |
| standard treatmentstandard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017. | Other | Intervention, Standard care |
Primary outcome
mHLA-DR expression
Time frame: 7 days
mHLA-DR expression
5 secondary outcomes
survival rate
Time frame: 28 days
Reduction of total bilirubin
Time frame: 7 days
hepatic encephalopathy grading
Time frame: 28 days
subsequent bacterial infection
Time frame: 28 days
CD11b expression
Time frame: 7 days
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 16 Jun 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Acute-On-Chronic Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Very Low-volume Plasma Exchange in ACLF
Acute on Chronic Liver Failure (ACLF)
Recruiting
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DPMAS and standard treatment in people with Acute-On-Chronic Liver Failure and Acute on Chronic Hepatic Failure, run by Chulalongkorn University at 1 site in Thailand.
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 3 inclusion and 7 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 16 Jun 2026. 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 Thailand. 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 Phatadon Sirivongrangson, MD ((+66)0852447788, phatadon@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mHLA-DR expression (time frame: 7 days). 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 16 Jun 2026.