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

Phase 4

Recruiting

• Conditions: Hepatitis B, Chronic; Thrombocytopenia; Acute-On-Chronic Liver Failure
• Interventions: Other: Artificial Liver Support System; Drug: Avatrombopag; Other: Comprehensive internal medical treatment.

• Registration Number: NCT05382013
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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 support system treatment.

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) 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.

Study Timeline

• Study Start: 2022-04-27
• Study First Submitted: 2022-05-14
• Study First Submitted QC: 2022-05-14
• Study First Posted: 2022-05-19
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-08
• Last Update Posted: 2022-11-10
• Primary Completion: 2024-02-29
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Comprehensive internal medical treatment.	30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.
Control Group	Artificial Liver Support System	30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.
Trial Group	Artificial Liver Support System	30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment.
Trial Group	Comprehensive internal medical treatment.	30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment.
Trial Group	Avatrombopag	30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment.

Primary Outcome Measures

Name	Time	Method
Rate of platelet ≥50*10E9/L	3 weeks	Rate of patients with platelet ≥50\*10E9/L during ALSS treatment

Secondary Outcome Measures

Name	Time	Method
Rate of bleeding	3 weeks	Incident rate of patients with bleeding during treatment

Trial Locations

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China