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

Phase 4UnknownNCT05382013

Third Affiliated Hospital, Sun Yat-Sen University60 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

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

Interventions

AvatrombopagDRUG

Patients will receive treatment of oral avatrombopag 20mg per day for the first 5 days

Artificial Liver Support SystemOTHER

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.OTHER

Patients will receive comprehensive internal medical treatment.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Rate of platelet ≥50*10E9/L

Rate of patients with platelet ≥50\*10E9/L during ALSS treatment

Time frame: 3 weeks

Secondary Outcomes

Rate of bleeding

Incident rate of patients with bleeding during treatment

Time frame: 3 weeks

Central Contacts

Wenxiong Xu, Doctor

CONTACT

+8613760783281 xwx1983@163.com

Liang Peng, Doctor

CONTACT

+8613533978874 pzp33@hotmail.com

Data from ClinicalTrials.gov

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