RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of HBV Related ACLF

N/AUnknownNCT04195282

Third Affiliated Hospital, Sun Yat-Sen University20 enrolled

Overview

This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with 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. RL-1 Novel Human-derived Bio-artificial Liver treatment may be an effective and safe therapy due to the previous clinical data. This study is to investigate the clinical efficacy and safety of RL-1 Novel Human-derived Bio-artificial Liver treatment in patients with HBV related ACLF.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B Acute-On-Chronic Liver Failure

Interventions

Plasma exchangeOTHER

Patients will receive treatment of plasma exchange for three times in two weeks. The volume of fresh frozen plasma used in plasma exchange is about 2000 millilitre per time.

RL-1 Novel Human-derived Bio-artificial Liver TreatmentOTHER

Patients will receive RL-1 Novel Human-derived Bio-artificial Liver treatment for three times in two weeks. The volume of plasma exchanged in the system is about 4000 millilitre per time.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Positive hepatitis b surface antigen or hepatitis b virus DNA \> 0.5 year; 2. Age from 18 to 65 years old; 3. Serum total bilirubin level \> 10 times upper limit of normal; 4. Prothrombin time activity \< 40% and ≥30%； 5. 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; 6. Other important organ dysfunctions; 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

Outcomes

Primary Outcomes

Adverse events

All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up.

Time frame: 4 week

Secondary Outcomes

Survival rate

Whether patients will survive after treatment is observed in the follow-up.

Time frame: 4 week

Symptoms

All symptoms (i.e. fatigue, appetite, nausea, vomiting, jaundice, consciousness) are observed in the follow-up.

Time frame: 4 week

Blood cells

Blood cells are observed in the follow-up.

Time frame: 4 week

Alanine transaminase

Alanine transaminase is observed in the follow-up.

Time frame: 4 week

Total bilirubin

Total bilirubin is observed in the follow-up.

Time frame: 4 week

Serum creatinine

is observed in the follow-up.

Time frame: 4 week

Prothrombin time

Prothrombin time is observed in the follow-up.

Time frame: 4 week

Blood ammonia

Blood ammonia is observed in the follow-up.

Time frame: 4 week

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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