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DPMAS Therapy in Liver Disease PatientsPADSTONENCT05129904

Precise Profiling of Liver Disease Patients With DPMAS Therapy, Treating Optimal Patients and Achieving Hard Endpoint (PADSTONE Study)

An observational study of DPMAS Therapy in Liver Disease Patients, run by Nanfang Hospital, Southern Medical University at 56 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Acute-on-chronic liver failure (ACLF) is a life-threatening syndrome occurring in patients with chronic liver disease. In China, hepatitis B virus (HBV) is the main cause of cirrhosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
DPMAS Therapy in Liver Disease Patients
What is being tested?
Double plasma molecular absorption system
How many people
1,300 participants
Where
56 sitesChina
Study dates
15 Sep 2021to 30 Sep 2026
Phase
Observational
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

Study population: Given the global heterogeneity of current regional diagnostic criteria for ACLF, the study enrolled a subgroup of patients with chronic liver disease (CLD) related ACLF defined by total bilirubin ≥ 12 mg/dL and INR level ≥ 1.5, which simultaneously fulfilled the diagnostic criteria recommended by Chinese and Asia-Pacific, while a considerable proportion also fulfilled the ACLF diagnostic criteria defined by European guidelines. This study population is characterized by markedly elevated bilirubin levels, making it well aligned with real-world clinical practice given that DPMAS intervention selectively targets bilirubin adsorption. Additionally, previous data have suggested that this specific patient population associated with a high rate of disease progression rate (approximately 40%) and high mortality (over 20%), further suggesting that the enrolled population is suitable for screening the optimal ACLF subgroup with favorable responses to DPMAS.

Who may be able to join

  • Hospitalized patients
  • Age >18 years
  • Chronic liver disease regardless of the etiology
  • Total bilirubin ≥ 12mg/dl and INR ≥ 1.5

Who cannot join

  • With ≥ 3 organ failures (SOFA criteria);
  • The pregnant;
  • With severe non-hepatic disease (such as chronic obstructive pulmonary disease level IV, chronic kidney disease with end-stage renal failure, myocardial infarction within 3 months before admission);
  • Human immunodeficiency virus (HIV) infection without treatment;
  • Patients with unstable hemodynamics caused by infection or acute bleeding;
  • Hospital stays <48 hours;
Show all 11Show fewer
  • Diagnosis of hepatocellular carcinoma during screening period;
  • For the DPMAS clusters: patients decline to receive DPMAS treatment alone or in combination with PE;
  • For the SOC clusters: patients plan to receive DPMAS therapy;
  • Not suitable to participate in this study judging by researchers (e.g., patients with severe advanced pancreatic tumors, hematological tumors);
  • Not sign the informed consent.

Trial locations and contacts

56 sites in 1 country.

56 sites in 1 country

China56 sites
  • Beijing Ditan Hospital, Capital Medical University

    Beijing

  • Beijing Youan Hospital, Capital Medical University

    Beijing

  • Luhe Hospital, Capital Medical University

    Beijing

  • Peking University People's Hospital

    Beijing

  • The First Hospital of Jilin University

    Changchun, Jilin

  • Hunan Provincial People's Hospital

    Changsha, Hunan

  • Xiangya Hospital of Central South University

    Changsha, Hunan

  • The Second Xiangya Hospital, Central South University

    Changsha

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Chengdu Public Health Clinical Center

    Chengdu

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • Southwest Hospital, Third Military Medical University

    Chongqing

  • The First People's Hospital of Foshan

    Foshan

  • First Affiliated Hospital of Fujian Medical University

    Fujian

  • Mengchao Hepatobiliary Hospital of Fujian Medical University

    Fujian

  • The First Affiliated Hospital of Guangxi Medical University

    Guangxi

  • The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine

    Guangxi

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Guangxi

  • The Second Affiliated Hospital of Guangxi Medical University

    Guangxi

  • Nanfang Hospital

    Guangzhou, Guangdong, 510515

  • Guizhou Provincial People's Hospital

    Guizhou

  • The Affiliated Hospital of Guizhou Medical University

    Guizhou

  • The Affiliated Hospital of Zunyi Medical University

    Guizhou

  • Hainan Provincial People's Hospital

    Hainan

  • The Third Hospital of Hebei Medical University

    Hebei, Hebei

  • The Second Hospital of Hebei Medical University

    Hebei

  • First Affiliated Hospital of Anhui Medical University

    Hefei

  • Henan Provincial People's Hospital

    Henan

  • Taihe Hospital, Hubei University of Medicine

    Hubei

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Hubei

  • Qilu Hospital of Shandong University

    Jinan, Shandong

  • Shandong Provincial Clinical Center for Public Health

    Jinan, Shandong

  • The First Affiliated Hospital of Shandong First Medical University

    Jinan, Shandong

  • The Second Hospital of Shandong University

    Jinan, Shandong

  • The First Hospital of Yunnan Province

    Kunming, Yunnan

  • The Second Affiliated Hospital of Kunming Medical University

    Kunming

  • The First Hospital of Lanzhou University

    Lanzhou

  • Zhengzhou University Affiliated Luoyang Centre Hospital

    Luoyang

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The Second Affiliated Hospital Of Nanchang University

    Nanchang, Jiangxi

  • Infectious Diseases Hospital Affiliated to Nanchang University

    Nanchang

  • Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu

  • General Hospital of Ningxia Medical University

    Qinghai

  • Huashan Hospital, Fudan University

    Shanghai

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai

  • Shanghai Jiao Tong University Affiliated Sixth People's Hospital

    Shanghai

  • Shanghai Public Health Clinical Centre, Fudan University

    Shanghai

  • Shanghai Public Health Clinical Centre

    Shanghai

  • The First Affiliated Hospital of Shanxi Medical University

    Shanxi

  • Tianjin Third Central Hospital

    Tianjin

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • The First Affiliated Hospital of Xinjiang Medical University

    Xinjiang

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Zhejiang

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: Precise Profiling of Liver Disease Patients With DPMAS Therapy, Treating Optimal Patients and Achieving Hard Endpoint: a Multicenter, Cluster-controlled Study (PADSTONE Study)

Acute-on-chronic liver failure (ACLF) is a life-threatening syndrome occurring in patients with chronic liver disease. In China, hepatitis B virus (HBV) is the main cause of cirrhosis. HBV related ACLF is characterized by multiple organs failure (liver, coagulation and kidney, etc.) and confers with high risk of short-term mortality. For the treatment of ACLF patients, recent studies have explored the therapeutic efficacy of extracorporeal liver support therapies, such as albumin dialysis, plasma exchange. However, the clinical efficacy remains to be fully elucidated. Liver transplantation is the most efficient way to improve the survival of ACLF patients, especially for those suffering from three or more organ failures.

Recently, a novel extracorporeal system which is called double plasma molecular adsorption system (DPMAS) has been applied for the treatment of ACLF patients. DPMAS is an extracorporeal therapeutic procedure that combines two hemoperfusion devices. During treatment, toxic plasma is isolated and purified via perfusion through two adsorbers, after which the purified plasma is reinfused back into the patient's circulation. This technique requires no massive plasma supply and avoids the risks of plasma-related allergic reactions and pathogen transmission. DPMAS can rapidly alleviate jaundice and lower serum bilirubin levels, thereby mitigating the hepatotoxic effects induced by excessive bilirubin and bile acids. Despite the widespread clinical application of DPMAS in patients with liver failure, high-quality evidence supporting its definite clinical efficacy remains insufficient.

Accordingly, this prospective, multicenter cluster-controlled study is designed to evaluate the clinical benefits of DPMAS via validated hard clinical endpoints, including short-term mortality and disease progression, and screen out suitable candidate patients. Furthermore, biological specimens including plasma, urine and feces will be collected to characterize the molecular profiles of ACLF patients receiving DPMAS treatment through multi-omics analyses.

Being tested
Double plasma molecular absorption system
Keywords
double plasma molecular absorption system, liver disease, acute-on-chronic liver failure, mortality
Medical subject headings
Liver Diseases, Acute-On-Chronic Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Double plasma molecular absorption systemOther

    Also called DPMAS treatment

    As a type of ECLS, double plasma molecular adsorption system (DPMAS) integrates plasma filtration with two specific adsorption membranes, which can efficiently remove bilirubin and the middle-molecular toxins, respectively. In the DPMAS clusters, patients receive at least one DPMAS treatment session during the study period, as treatment details regarding the number of DPMAS sessions and session intervals are made upon institutional protocols. DPMAS treatment can be applied either alone or in combination with PE, and both modalities are permitted in this study. PE is allowed in both groups as standard supportive care.

Study groups in NCT05129904
Study groupRoleWhat they receive
Double plasma molecular absorption system treatmentPatients in DPMAS clusters receive at least one DPMAS treatment session (with or without plasma exchange) in this study.
Receives: Other: Double plasma molecular absorption system
Standard of carePatients in the SOC clusters receive routine treatments other than DPMAS, in accordance with established clinical guidelines for the management of ACLF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The rate of progression within 4 weeks

    The progression of ACLF within 4 weeks

    Measured: 4 weeks

  2. The 4-week transplant-free mortality

    The 4-week transplant-free mortality

    Measured: 4 weeks

Secondary outcomes (2)
  1. The transplant-free mortality within 12 weeks

    The transplant-free mortality within 12 weeks

    Measured: 12 weeks

  2. The progression of ACLF within 12 weeks

    The progression rate of ACLF within 12 weeks

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2021
  2. Study start15 Sep 2021
  3. Primary completion30 Dec 2024
  4. Study completion30 Sep 2026 (estimated)

Resources

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
Other
Time perspective
Prospective
Enrolment
1,300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05129904
Sponsor's protocol ID
NFEC-2021-259
Acronym
PADSTONE
Status last verified
May 2026
First submitted
31 Oct 2021
Last updated
26 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of DPMAS Therapy in Liver Disease Patients, run by Nanfang Hospital, Southern Medical University at 56 sites 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 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: under way, not looking for participants, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of progression within 4 weeks (time frame: 4 weeks). 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 26 May 2026.

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