Back to resultsRL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of HBV Related ACLF
Primary Purpose
Hepatitis B, Acute-On-Chronic Liver Failure
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Plasma exchange
RL-1 Novel Human-derived Bio-artificial Liver Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B focused on measuring hepatitis b virus, acute-on-chronic liver failure, artificial liver
Eligibility Criteria
Inclusion Criteria:
- Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
- Age from 18 to 65 years old;
- Serum total bilirubin level > 10 times upper limit of normal;
- Prothrombin time activity < 40% and ≥30%；
- Platelets > 50*10 E9/L.
Exclusion Criteria:
- Other active liver diseases;
- Hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases;
- Severe diabetes, autoimmune diseases;
- Other important organ dysfunctions;
- Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
- Patients can not follow-up;
- Investigator considering inappropriate.
Sites / Locations
- Third Affiliated Hospital of Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Plasma exchange group
RL-1 Novel Human-derived Bio-artificial Liver treatment group
Arm Description
10 patients will receive conventional treatment plus plasma exchange
10 patients will receive conventional treatment plus RL-1 Novel Human-derived Bio-artificial Liver treatment
Outcomes
Primary Outcome Measures
Adverse events
All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up.
Secondary Outcome Measures
Survival rate
Whether patients will survive after treatment is observed in the follow-up.
Symptoms
All symptoms (i.e. fatigue, appetite, nausea, vomiting, jaundice, consciousness) are observed in the follow-up.
Blood cells
Blood cells are observed in the follow-up.
Alanine transaminase
Alanine transaminase is observed in the follow-up.
Total bilirubin
Total bilirubin is observed in the follow-up.
Serum creatinine
is observed in the follow-up.
Prothrombin time
Prothrombin time is observed in the follow-up.
Blood ammonia
Blood ammonia is observed in the follow-up.
Full Information
NCT ID
NCT04195282
First Posted
December 8, 2019
Last Updated
December 10, 2019
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT04195282
Brief Title
RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of HBV Related ACLF
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Acute-On-Chronic Liver Failure
Keywords
hepatitis b virus, acute-on-chronic liver failure, artificial liver
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plasma exchange group
Arm Type
Active Comparator
Arm Description
10 patients will receive conventional treatment plus plasma exchange
Arm Title
RL-1 Novel Human-derived Bio-artificial Liver treatment group
Arm Type
Experimental
Arm Description
10 patients will receive conventional treatment plus RL-1 Novel Human-derived Bio-artificial Liver treatment
Intervention Type
Other
Intervention Name(s)
Plasma exchange
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
RL-1 Novel Human-derived Bio-artificial Liver Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse events
Description
All adverse events (i.e. fever, allergy, bleeding, hypotension, thrombosis) are observed in the follow-up.
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Survival rate
Description
Whether patients will survive after treatment is observed in the follow-up.
Time Frame
4 week
Title
Symptoms
Description
All symptoms (i.e. fatigue, appetite, nausea, vomiting, jaundice, consciousness) are observed in the follow-up.
Time Frame
4 week
Title
Blood cells
Description
Blood cells are observed in the follow-up.
Time Frame
4 week
Title
Alanine transaminase
Description
Alanine transaminase is observed in the follow-up.
Time Frame
4 week
Title
Total bilirubin
Description
Total bilirubin is observed in the follow-up.
Time Frame
4 week
Title
Serum creatinine
Description
is observed in the follow-up.
Time Frame
4 week
Title
Prothrombin time
Description
Prothrombin time is observed in the follow-up.
Time Frame
4 week
Title
Blood ammonia
Description
Blood ammonia is observed in the follow-up.
Time Frame
4 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Positive hepatitis b surface antigen or hepatitis b virus DNA > 0.5 year;
Age from 18 to 65 years old;
Serum total bilirubin level > 10 times upper limit of normal;
Prothrombin time activity < 40% and ≥30%；
Platelets > 50*10 E9/L.
Exclusion Criteria:
Other active liver diseases;
Hepatocellular carcinoma or other malignancy;
Pregnancy or lactation;
Human immunodeficiency virus infection or congenital immune deficiency diseases;
Severe diabetes, autoimmune diseases;
Other important organ dysfunctions;
Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
Patients can not follow-up;
Investigator considering inappropriate.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenxiong Xu, Doctor
Phone
+8613760783281
Email
xwx1983@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of HBV Related ACLF
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