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

Therapeutic Effects and Safety of RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of Hepatitis b Virus Related Acute-on-chronic Liver Failure

NCT04195282•Third Affiliated Hospital, Sun Yat-Sen University

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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.

Eligibility

Age

18 - 65 years

Sex

ALL

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.

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

December 1, 2019

Primary Completion Date

December 1, 2021

Completion Date

December 1, 2021

Last Updated

December 11, 2019

Enrollment

ESTIMATED participants

Conditions

Hepatitis BAcute-On-Chronic Liver Failure

Interventions

Plasma exchange

OTHER

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

OTHER

Contacts

Wenxiong Xu, Doctor

CONTACT

+8613760783281 xwx1983@163.com

Liang Peng, Doctor

CONTACT

+8613533978874 pzp33@hotmail.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of GIGA-2339 in Participants With Chronic Hepatitis B Virus Infection

Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B

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