Efficacy and Safety of Avatrombopag for Treating TCP in HBV-ACLF Patients Receiving ALSS Treatment
NCT ID: NCT05382013
Last Updated: 2022-11-10
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
PHASE4
60 participants
INTERVENTIONAL
2022-04-27
2024-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Trial Group
30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment.
Avatrombopag
Patients will receive treatment of oral avatrombopag 20mg per day for the first 5 days
Artificial Liver Support System
Patients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (LPE) for three times. The volume of plasma adsorption in DPMAS is 5000\~6000 millilitre. The volume of fresh frozen plasma used in LPE is 1000 millilitre.
Comprehensive internal medical treatment.
Patients will receive comprehensive internal medical treatment.
Control Group
30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.
Artificial Liver Support System
Patients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (LPE) for three times. The volume of plasma adsorption in DPMAS is 5000\~6000 millilitre. The volume of fresh frozen plasma used in LPE is 1000 millilitre.
Comprehensive internal medical treatment.
Patients will receive comprehensive internal medical treatment.
Interventions
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Avatrombopag
Patients will receive treatment of oral avatrombopag 20mg per day for the first 5 days
Artificial Liver Support System
Patients will receive treatment of double plasma molecular adsorption system (DPMAS) and low volume plasma exchange (LPE) for three times. The volume of plasma adsorption in DPMAS is 5000\~6000 millilitre. The volume of fresh frozen plasma used in LPE is 1000 millilitre.
Comprehensive internal medical treatment.
Patients will receive comprehensive internal medical treatment.
Eligibility Criteria
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Inclusion Criteria
2. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
3. Clinical diagnosis of liver failure (serum total bilirubin level \> 10 times upper limit of normal; prothrombin time activity \< 40% and ≥20%, or prothrombin time international ratio ≤ 2.6 and \> 1.5);
4. Platelets \< 80\*10 E9/L and \> 50\*10 E9/L.
5. Signed informed consent form.
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; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;
6. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
7. Patients with ALSS treatment in one week;
8. Thrombotic disease;
9. Patients can not follow-up;
10. 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
Professor
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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Other Identifiers
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PL16
Identifier Type: -
Identifier Source: org_study_id
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