Combining DPMAS and Low Volume Plasma Exchange for Hepatitis B Related Liver Failure

Double Plasma Molecular Adsorption System With Sequential Low-Dose Plasma Exchange in Patients With Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Prospective Cohort Study

This study is testing a new treatment combining a special blood filtering system and plasma exchange to see if it helps people with liver failure caused by hepatitis B feel better and improve their health.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT04597164 on ClinicalTrials.gov

What this trial studies

This study investigates the safety and efficacy of a combination treatment using the Double Plasma Molecular Adsorption System (DPMAS) and low-volume plasma exchange (PE) for patients suffering from hepatitis B virus-related acute-on-chronic liver failure (ACLF). The trial will enroll 200 patients who will be divided into a treatment group receiving DPMAS, low-volume PE, and comprehensive internal medical treatment, and a control group receiving only comprehensive internal medical treatment. The study will monitor symptoms, laboratory test results, adverse events, and mortality rates over a 12-week period to assess the effectiveness of the combined treatment approach.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with chronic hepatitis B infection and clinical liver failure.

Not a fit: Patients with other active liver diseases, malignancies, or severe complications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with HBV-related ACLF, potentially improving survival rates and quality of life.

How similar studies have performed: Previous clinical data suggest that non-bioartificial liver support systems may be effective, indicating potential success for this novel combination approach.

Eligibility criteria

Inclusion Criteria:

1. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
2. Age from 18 to 65 years old;
3. 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);
4. Platelets \> 50\*10 E9/L.

Exclusion Criteria:

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

Where this trial is running

Guangzhou, Guangdong

• Third Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Liang Peng, Doctor — Third Affiliated Hospital, Sun Yat-Sen University
• Study coordinator: Wenxiong Xu, Doctor

Conditions: Hepatitis B, Chronic, Acute-On-Chronic Liver Failure, hepatitis b virus, acute-on-chronic liver failure, double plasma molecular adsorption system, plasma exchange