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

Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04195282
• Other study ID #: PL9
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 2019
• Est. completion date: December 2021

Study information

• Verified date: December 2019
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Wenxiong Xu, Doctor
• Phone: +8613760783281
• Email: xwx1983[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Failure

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up.	4 week
Secondary	Survival rate	Whether patients will survive after treatment is observed in the follow-up.	4 week
Secondary	Symptoms	All symptoms (i.e. fatigue, appetite, nausea, vomiting, jaundice, consciousness) are observed in the follow-up.	4 week
Secondary	Blood cells	Blood cells are observed in the follow-up.	4 week
Secondary	Alanine transaminase	Alanine transaminase is observed in the follow-up.	4 week
Secondary	Total bilirubin	Total bilirubin is observed in the follow-up.	4 week
Secondary	Serum creatinine	is observed in the follow-up.	4 week
Secondary	Prothrombin time	Prothrombin time is observed in the follow-up.	4 week
Secondary	Blood ammonia	Blood ammonia is observed in the follow-up.	4 week