NCT04195282

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B
• Acute-On-Chronic Liver Failure

Interventions

Type	Name	Description
OTHER	Plasma exchange	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.
OTHER	RL-1 Novel Human-derived Bio-artificial Liver Treatment	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.

Timeline

• Start date: 2019-12-01
• Primary completion: 2021-12-01
• Completion: 2021-12-01
• First posted: 2019-12-11
• Last updated: 2019-12-11

Locations

1 site across 1 country: China