Actively Recruiting
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2024-11-29
200
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the safety and effectiveness of combining a Double Plasma Molecular Adsorption System (DPMAS) with sequential low-dose plasma exchange (PE) to treat patients with hepatitis B virus-related acute-on-chronic liver failure (ACLF). This serious liver condition has a high mortality rate, and current effective treatments are limited mainly to liver transplantation. The study aims to provide evidence for this combination therapy as a potential treatment option. The study includes two groups: one group of 100 patients will receive the combined DPMAS and low volume PE treatments along with comprehensive internal medical care. The DPMAS involves processing 5000 to 6000 milliliters of plasma, and the PE uses 1000 milliliters of fresh frozen plasma, with treatments administered three times. The other 100 patients will receive comprehensive internal medical treatment alone. This research is conducted across six medical centers. Participants will be monitored from the start of treatment through 12 weeks. Researchers will record symptoms, signs, lab test results, adverse events, and mortality or liver transplantation rates. They will also assess changes in the Model for End-Stage Liver Disease (MELD) score over this period. The study focuses on safety and clinical outcomes to understand how well the combination therapy works and its impact on patients living with HBV-related ACLF.
CONDITIONS
Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants in the artificial liver support system group receive treatment consisting of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (PE) three times, along with comprehensive internal medical treatment. Participants in the control group receive comprehensive internal medical treatment only.
3 treatment visits for DPMAS and PE plus additional visits for medical treatment as needed
Duration - 12 weeks from treatment baseline
Participants are monitored for symptoms, signs, laboratory test results, adverse events, and mortality rates from treatment baseline through 12 weeks.
Regular visits during the 12-week period for assessments
Total: 1 location
1
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
W
Wenxiong Xu, Doctor
L
Liang Peng, Doctor
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Wenxiong Xu, Shu Zhu, Luo Yang...
https://pubmed.ncbi.nlm.nih.gov/36897008Wenxiong Xu, Yangmei Li, Lu Wang...
https://pubmed.ncbi.nlm.nih.gov/34907041