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

Recruiting

• Conditions: Acute-On-Chronic Liver Failure; Hepatitis B, Chronic
• Interventions: Other: Artificial liver support system

• Registration Number: NCT04597164
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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.

Detailed Description

Hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF) is a serious condition with high mortality rate in China. But there still lacks of effective therapies in treatment of HBV related ACLF, except liver transplantation. Non-bioartificial liver support system treatments may be effective due to previous clinical data. Plasma exchange (PE) and double plasma molecular adsorption system (DPMAS) are two common ways in clinical practice. This study is to investigate the clinical efficacy and safety of combination treatment of DPMAS and low volume PE in patients with HBV related ACLF. This study will be completed in 6 medical center. Two hundred patients with HBV related ACLF enrolled in this study are divided into trial group (DPMAS, low volume PE, and comprehensive internal medical treatment) and control group (comprehensive internal medical treatment). Symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 12 weeks.

Study Timeline

• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-20
• Study First Posted: 2020-10-22
• Study Start: 2020-12-22
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Artificial liver support system group	Artificial liver support system	100 patients in this group will receive treatment of double plasma molecular adsorption system, low volume plasma exchange, and comprehensive internal medical treatment

Primary Outcome Measures

Name	Time	Method
Mortality or liver transplantation rate	12 weeks	Mortality or liver transplantation rate at 12-week follow-up.

Secondary Outcome Measures

Name	Time	Method
Model for end-stage liver disease (MELD) score variation	12 weeks	Variation of MELD score at 12 weeks after treatment. MELD score = 9.57 × loge(creatinine mg/dl) + 3.78 × loge(TBIL mg/dl) + 11.20 × loge(PT-INR) + 6.43.

Trial Locations

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China