Efficacy and Safety of Avatrombopag for Treating TCP in HBV-ACLF Patients Receiving ALSS Treatment

Sun Yat-sen University

Status and phase: Enrolling; Phase 4

Conditions: Acute-On-Chronic Liver Failure; Thrombocytopenia; Hepatitis B, Chronic

Treatments: Other: Comprehensive internal medical treatment.; Other: Artificial Liver Support System; Drug: Avatrombopag

Study type: Interventional

Funder types: Other

Identifiers

NCT05382013

PL16

Details and patient eligibility

About

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 support system treatment.

Full 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) due to the mechanical damage of thrombocyte and use of heparin during the treatment. Avatrombopag is an oral thrombopoietin receptor agonist that has been recently approved for treating TCP in chronic liver disease patients needing invasive procedures. Therefore, this study aims to investigate the efficacy and safety of avatrombopag for treating TCP in HBV related ACLF patients receiving ALSS treatment. Sixty patients with HBV related ACLF receiving ALSS will be enrolled in this study. The participants are divided into trial group (avatrombopag, double plasma molecular adsorption system (DPMAS) , low volume plasma exchange (LPE), and comprehensive internal medical treatment) and control group (DPMAS, LPE, comprehensive internal medical treatment). Symptoms, signs, laboratory tests results, adverse events, mortality rates are recorded from treatment baseline to 3 weeks.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age from 18 to 65 years old;
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

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; 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Trial Group

Experimental group

Description:

30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment.

Treatment:

Drug: Avatrombopag

Other: Comprehensive internal medical treatment.

Other: Artificial Liver Support System

Control Group

Active Comparator group

Description:

30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.

Treatment:

Other: Comprehensive internal medical treatment.

Other: Artificial Liver Support System