Clinical trial NCT04597164: Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B, Chronic
Acute-On-Chronic Liver Failure
Keywords: hepatitis b virus
acute-on-chronic liver failure
double plasma molecular adsorption system
plasma exchange
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This prospective study included patients diagnosed with HBV-ACLF at the Department of Infectious Diseases, the Third Affiliated Hospital of Sun Yat-sen University (Guangdong Province, China).

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.

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.

Primary outcomes:
measure: Mortality or liver transplantation rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Model for end-stage liver disease (MELD) score variation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Liang Peng, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Xu W, Li Y, Wang L, Gao H, Chen J, Yuan J, Ouyang Y, Gao Y, Li J, Li X, Peng L. Efficacy and safety of combination treatment of double plasma molecular adsorption system and low volume plasma exchange for patients with hepatitis B virus related acute-on-chronic liver failure: a multicentre randomised controlled clinical trial. BMJ Open. 2021 Dec 14;11(12):e047690. doi: 10.1136/bmjopen-2020-047690.