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

Not Applicable

• Conditions: Hepatitis B; Acute-On-Chronic Liver Failure
• Interventions: Other: Plasma exchange; Other: RL-1 Novel Human-derived Bio-artificial Liver Treatment

• Registration Number: NCT04195282
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

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.

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. 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 Timeline

• Status Verified: 2019-12
• Study Start: 2019-12
• Study First Submitted: 2019-12-08
• Study First Submitted QC: 2019-12-10
• Last Update Submitted: 2019-12-10
• Study First Posted: 2019-12-11
• Last Update Posted: 2019-12-11
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasma exchange group	Plasma exchange	10 patients will receive conventional treatment plus plasma exchange
RL-1 Novel Human-derived Bio-artificial Liver treatment group	RL-1 Novel Human-derived Bio-artificial Liver Treatment	10 patients will receive conventional treatment plus RL-1 Novel Human-derived Bio-artificial Liver treatment

Primary Outcome Measures

Name	Time	Method
Adverse events	4 week	All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up.

Secondary Outcome Measures

Name	Time	Method
Symptoms	4 week	All symptoms (i.e. fatigue, appetite, nausea, vomiting, jaundice, consciousness) are observed in the follow-up.
Survival rate	4 week	Whether patients will survive after treatment is observed in the follow-up.
Prothrombin time	4 week	Prothrombin time is observed in the follow-up.
Alanine transaminase	4 week	Alanine transaminase is observed in the follow-up.
Total bilirubin	4 week	Total bilirubin is observed in the follow-up.
Blood ammonia	4 week	Blood ammonia is observed in the follow-up.
Serum creatinine	4 week	is observed in the follow-up.
Blood cells	4 week	Blood cells are observed in the follow-up.

Trial Locations

Locations (1)

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