Back to resultsEfficacy and Safety of Avatrombopag for Treating TCP in HBV-ACLF Patients Receiving ALSS Treatment
Primary Purpose
Thrombocytopenia, Hepatitis B, Chronic, Acute-On-Chronic Liver Failure
Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Avatrombopag
Artificial Liver Support System
Comprehensive internal medical treatment.
Sponsored by
About this trial
This is an interventional prevention trial for Thrombocytopenia focused on measuring thrombocytopenia, hepatitis B virus, acute-on-chronic liver failure, double plasma molecular adsorption system, plasma exchange, artificial liver support system
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Third Affiliated Hospital of Sun Yat-sen UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Trial Group
Control Group
Arm Description
30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment.
30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.
Outcomes
Primary Outcome Measures
Rate of platelet ≥50*10E9/L
Rate of patients with platelet ≥50*10E9/L during ALSS treatment
Secondary Outcome Measures
Rate of bleeding
Incident rate of patients with bleeding during treatment
Full Information
NCT ID
NCT05382013
First Posted
May 14, 2022
Last Updated
November 8, 2022
Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT05382013
Brief Title
Efficacy and Safety of Avatrombopag for Treating TCP in HBV-ACLF Patients Receiving ALSS Treatment
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
April 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Trial Group
Arm Type
Experimental
Arm Description
30 patients receive treatment of avatrombopag, DPMAS, LPE, and comprehensive internal medical treatment.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
30 patients receive treatment of DPMAS, LPE, and comprehensive internal medical treatment.
Intervention Type
Drug
Intervention Name(s)
Avatrombopag
Intervention Description
Patients will receive treatment of oral avatrombopag 20mg per day for the first 5 days
Intervention Type
Other
Intervention Name(s)
Artificial Liver Support System
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive internal medical treatment.
Intervention Description
Patients will receive comprehensive internal medical treatment.
Primary Outcome Measure Information:
Title
Rate of platelet ≥50*10E9/L
Description
Rate of patients with platelet ≥50*10E9/L during ALSS treatment
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Rate of bleeding
Description
Incident rate of patients with bleeding during treatment
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wenxiong Xu, Doctor
Phone
+8613760783281
Email
xwx1983@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Organizational Affiliation
Third Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Peng, Doctor
Phone
+8613533978874
Email
pzp33@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The study protocol, results and conclusions of this clinical trial will be published at academic conferences or in journals.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing 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.
Learn more about this trial
Efficacy and Safety of Avatrombopag for Treating TCP in HBV-ACLF Patients Receiving ALSS Treatment
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