NCT05382013

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

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombocytopenia
• Hepatitis B, Chronic
• Acute-On-Chronic Liver Failure

Interventions

Type	Name	Description
DRUG	Avatrombopag	Patients will receive treatment of oral avatrombopag 20mg per day for the first 5 days
OTHER	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.
OTHER	Comprehensive internal medical treatment.	Patients will receive comprehensive internal medical treatment.

Timeline

• Start date: 2022-04-27
• Primary completion: 2024-02-29
• Completion: 2024-04-30
• First posted: 2022-05-19
• Last updated: 2022-11-10

Locations

1 site across 1 country: China