Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF

NCT04597164 | Recruiting

• 1 other identifier: PL13
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to investigate investigate the safety and efficacy of Double plasma molecular adsorption system with sequential low-dose plasma exchange in treating hepatitis B virus-related acute-on-chronic liver failure.

Conditions

Hepatitis B, Chronic; Acute-On-Chronic Liver Failure

Keywords

hepatitis b virus; acute-on-chronic liver failure; double plasma molecular adsorption system; plasma exchange

Outcome Measures

Primary Outcomes (1)

• Mortality or liver transplantation rate

  Mortality or liver transplantation rate at 12-week follow-up.

  12 weeks

Secondary Outcomes (1)

• Model for end-stage liver disease (MELD) score variation

  12 weeks

Study Arms (2)

Artificial liver support system group

100 patients in this group will receive treatment of double plasma molecular adsorption system, low volume plasma exchange, and comprehensive internal medical treatment

Other: Artificial liver support system

Comprehensive medical treatment group

100 patients in this group will receive comprehensive internal medical treatment.

Interventions

Artificial liver support system OTHER

Patients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (PE) for three times, and comprehensive internal medical treatment. The volume of plasma adsorption in DPMAS is 5000\~6000 millilitre. The volume of fresh frozen plasma used in PE is 1000 millilitre.

Artificial liver support system group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This prospective study included patients diagnosed with HBV-ACLF at the Department of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University (Guangdong Province, China).

You may qualify if:

• Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
• Age from 18 to 65 years old;
• Clinical diagnosis of liver failure (serum total bilirubin level \> 10 times upper limit of normal; prothrombin time activity \< 40% and ≥20%, or prothrombin time international ratio ≤ 2.6 and \> 1.5);
• Platelets \> 50\*10 E9/L.

You may not qualify if:

• Other active liver diseases;
• Hepatocellular carcinoma or other malignancy;
• Pregnancy or lactation;
• Human immunodeficiency virus infection or congenital immune deficiency diseases;
• Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events;
• Other important organ dysfunctions or transplantation;
• Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
• Patients can not follow-up;
• Investigator considering inappropriate.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

Related Publications (2)

• Xu W, Zhu S, Yang L, Li Z, Wu L, Zhang Y, Chen J, Deng Z, Luo Q, Peng L. Safety and efficacy of double plasma molecular adsorption system with sequential low-volume plasma exchange in intermediate-stage hepatitis B virus-related acute-on-chronic liver failure. J Med Virol. 2023 Mar;95(3):e28650. doi: 10.1002/jmv.28650.

  PMID: 36897008 DERIVED

• Xu W, Li Y, Wang L, Gao H, Chen J, Yuan J, Ouyang Y, Gao Y, Li J, Li X, Peng L. Efficacy and safety of combination treatment of double plasma molecular adsorption system and low volume plasma exchange for patients with hepatitis B virus related acute-on-chronic liver failure: a multicentre randomised controlled clinical trial. BMJ Open. 2021 Dec 14;11(12):e047690. doi: 10.1136/bmjopen-2020-047690.

  PMID: 34907041 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic; Acute-On-Chronic Liver Failure; Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency

Study Officials

• Liang Peng, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxiong Xu, Doctor

CONTACT

+8613760783281; xwx1983@163.com

Liang Peng, Doctor

CONTACT

+8613533978874; pzp33@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 22, 2020
• Study Start: December 22, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Proposals should be directed to pliang@mail.sysu.edu.cn. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)