Status:
UNKNOWN
Efficacy and Safety of Avatrombopag for Treating TCP in HBV-ACLF Patients Receiving ALSS Treatment
Lead Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Conditions:
Thrombocytopenia
Hepatitis B, Chronic
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This study aims to investigate the efficacy and safety of avatrombopag for treating thrombocytopenia in hepatitis b virus related acute-on-chronic liver failure patients receiving artificial liver sup...
Detailed Description
Artificial liver support system (ALSS) is an optimal therapy in patients with hepatitis b virus (HBV) related acute-on-chronic liver failure (ACLF). But a lot of patients encount thrombocytopenia (TCP...
Eligibility Criteria
Inclusion
- Age from 18 to 65 years old;
- Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
- 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);
- Platelets \< 80\*10 E9/L and \> 50\*10 E9/L.
- Signed informed consent form.
Exclusion
- 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; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;
- Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
- Patients with ALSS treatment in one week;
- Thrombotic disease;
- Patients can not follow-up;
- Investigator considering inappropriate.
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05382013
Start Date
April 27 2022
End Date
April 30 2024
Last Update
November 10 2022
Active Locations (1)
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1
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630