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

Sun Yat-sen University

Status: Unknown

Conditions: Acute-On-Chronic Liver Failure; Hepatitis B

Treatments: Other: RL-1 Novel Human-derived Bio-artificial Liver Treatment; Other: Plasma exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT04195282

PL9

Details and patient eligibility

About

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.

Full 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. 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Plasma exchange group

Active Comparator group

Description:

10 patients will receive conventional treatment plus plasma exchange

Treatment:

Other: Plasma exchange

RL-1 Novel Human-derived Bio-artificial Liver treatment group

Experimental group

Description:

10 patients will receive conventional treatment plus RL-1 Novel Human-derived Bio-artificial Liver treatment

Treatment:

Other: RL-1 Novel Human-derived Bio-artificial Liver Treatment