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

NCT05382013 | Unknown Phase 4

• 1 other identifier: PL16
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

thrombocytopenia; hepatitis B virus; acute-on-chronic liver failure; double plasma molecular adsorption system; plasma exchange; artificial liver support system

Outcome Measures

Primary Outcomes (1)

• Rate of platelet ≥50*10E9/L

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

  3 weeks

Secondary Outcomes (1)

• Rate of bleeding

  3 weeks

Study Arms (2)

Trial Group

EXPERIMENTAL

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

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

Control Group

ACTIVE COMPARATOR

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

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

Interventions

Avatrombopag DRUG

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

Trial Group

Artificial Liver Support System OTHER

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.

Control Group; Trial Group

Comprehensive internal medical treatment. OTHER

Patients will receive comprehensive internal medical treatment.

Control Group; Trial Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 to 65 years old;
• Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \> 0.5 year);
• 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);
• Platelets \< 80\*10 E9/L and \> 50\*10 E9/L.
• Signed informed consent form.

You may not qualify if:

• Other active liver diseases;
• Hepatocellular carcinoma or other malignancy;
• Pregnancy or lactation;
• Human immunodeficiency virus infection or congenital immune deficiency diseases;
• Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;
• Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;
• Patients with ALSS treatment in one week;
• Thrombotic disease;
• Patients can not follow-up;
• Investigator considering inappropriate.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

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

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure, Acute; Liver Failure; Hepatic Insufficiency

Study Officials

• Liang Peng, Doctor

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenxiong Xu, Doctor

CONTACT

+8613760783281; xwx1983@163.com

Liang Peng, Doctor

CONTACT

+8613533978874; pzp33@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 14, 2022
• First Posted: May 19, 2022
• Study Start: April 27, 2022
• Primary Completion: February 29, 2024
• Study Completion: April 30, 2024
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Proposals should be directed to pliang@mail.sysu.edu.cn. To gain access, data requestors will need to sign a data access agreement.

Locations

CN (1)