RL-1 Novel Human-derived Bio-artificial Liver Treatment in Patients of HBV Related ACLF
NCT ID: NCT04195282
Last Updated: 2019-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2019-12-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Plasma exchange group
10 patients will receive conventional treatment plus plasma exchange
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 group
10 patients will receive conventional treatment plus RL-1 Novel Human-derived Bio-artificial Liver treatment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
65 Years
ALL
No
Sponsors
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Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
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Liang Peng
Professer
Principal Investigators
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Liang Peng, Doctor
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital, Sun Yat-Sen University
Locations
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Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Liang Peng, Doctor
Role: primary
Other Identifiers
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PL9
Identifier Type: -
Identifier Source: org_study_id