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

Third Affiliated Hospital, Sun Yat-Sen University200 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

200

Conditions

Hepatitis B, Chronic Acute-On-Chronic Liver Failure

Interventions

Artificial liver support systemOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Mortality or liver transplantation rate

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

Time frame: 12 weeks

Secondary Outcomes

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

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.

Time frame: 12 weeks

Central Contacts

Wenxiong Xu, Doctor

CONTACT

+8613760783281 xwx1983@163.com

Liang Peng, Doctor

CONTACT

+8613533978874 pzp33@hotmail.com

Data from ClinicalTrials.gov

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