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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05382013
• Other study ID #: PL16
• Status: Recruiting
• Phase: Phase 4
• Start date: April 27, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: November 2022
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Wenxiong Xu, Doctor
• Phone: +8613760783281
• Email: xwx1983[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Hepatic Insufficiency
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Liver Failure
• Thrombocytopenia

Intervention

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.
• Comprehensive internal medical treatment.
Patients will receive comprehensive internal medical treatment.

Locations

Country	Name	City	State
China	Third Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of platelet =50*10E9/L	Rate of patients with platelet =50*10E9/L during ALSS treatment	3 weeks
Secondary	Rate of bleeding	Incident rate of patients with bleeding during treatment	3 weeks