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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: xwx1983@163.com
• Phone: +8613760783281

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.