Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

Phase 4

• Conditions: Thrombocytopenia; Liver Failure; Decompensated Cirrhosis
• Interventions: Drug: Avatrombopag; Drug: Standard medical treatment

• Registration Number: NCT04906083
• Lead Sponsor: Tongji Hospital

Brief Summary

End stage liver disease is prone to thrombocytopenia. This study is a multi-center, randomized, prospective, randomized controlled Phase IV Clinical trial to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia.

Detailed Description

End stage liver disease is prone to thrombocytopenia. This study aims to discuss the Efficacy and Safety of Avatrombopag in Patients with End-stage Liver Disease and Thrombocytopenia in a multicenter, prospective, randomized controlled trial. The patients were divided into one of the groups according to if receiving avatrombopag. Avatrombopag was taken to maintain platelet count 50\~100×10\^9/L. Starting dose is recommended according to the patient's baseline platelet count level. Routine treatment was taken in the Control group and Interventional group. This trial will take about 2 to 2.5 years from the first participant signing an informed consent form (ICF) until all study-related telephone follow-ups or visits end.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-26
• Study First Posted: 2021-05-28
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-03
• Last Update Posted: 2021-06-07
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Men and women greater than or equal to 18 years of age;
2. Baseline platelet count <50×10^9/L;
3. End-stage liver disease, including acute-on-chronic liver failure, acute decompensation of liver cirrhosis, chronic liver failure;
4. Women of childbearing potential must agree to use a highly effective method of contraception from the beginning of Baseline Visit until the end of treatment (includes implantable contraception, injectable contraception, hormonal combination contraception [including vaginal rings], intra-uterine devices or vasectomy). The barrier contraception with or without spermicide alone, double barrier contraception and oral contraceptives are inadequate;
5. Subject is able to understand the study and willing to follow the protocol and sign informed consent voluntarily before Baseline Visit;
6. Subject meet the criteria according to the opinion of the researchers.

Exclusion Criteria

1. Subject has a history of arterial or venous thrombosis within the previous 6 months of baseline;
2. Known portal vein blood flow velocity rate <10 cm/second or previous occurrence of a portal vein thrombosis within 6 months of Baseline;
3. Known any history of primary blood (e.g, immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia);
4. Subject has a known medical history of genetic prothrombotic syndromes (e.g, Factor V Leiden prothrombin G20210A, antithrombin III (AT III) deficiency);
5. Subject has a recent history (within the previous 6 months) of significant cardiovascular diseases (e.g., exacerbation of congestive heart failure, arrhythmias known to increase the risk of thromboembolic events [e.g. atrial fibrillation], coronary or peripheral artery stent placement or angioplasty, and coronary or peripheral artery bypass grafting);
6. Female subjects who are lactating or pregnant at the Baseline Visit (as documented by a positive serum beta-human chorionic gonadotropin [β-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG) or are planning to become pregnant during the study;
7. The subject has a hypersensitivity to Avatrombopag or any of its excipients;
8. Subjects with drug-induced thrombocytopenia;
9. Subjects whose Life expectation ≤6 months;
10. Subject with a current malignancy;
11. Subjects with HIV infection;
12. At screening, active infection was not effectively controlled by systemic antibiotic therapy;
13. The Investigator believe that any accompanying medical history may affect the safety of the subjects to complete the study;
14. The Investigator believe that there are any other factors that are not suitable for inclusion or affect participation or completion of the study;
15. Subject is enrolled in another clinical study with any investigational drug or device within previous 30 days of the Baseline Visit, but are allowed to participate in observational studies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Avatrombopag	Avatrombopag+Standard medical treatment
Intervention group	Standard medical treatment	Avatrombopag+Standard medical treatment
Control group	Standard medical treatment	Standard medical treatment

Primary Outcome Measures

Name	Time	Method
Platelet count response time	24 weeks	Platelet count response time(PLT) refers to condition of PLT during 24 weeks between the Intervention group and Control group.

Secondary Outcome Measures

Name	Time	Method
Patients without platelet transfusion or rescue due to bleeding	24 weeks	Patients without platelet transfusion or rescue due to bleeding refers to the patients rate without platelet transfusion or rescue due to bleeding between the two groups at 24 week
Adverse Event (thrombotic events, bleeding events, etc.) incidence;	24 weeks	Adverse Event refers to the incidence rate of adverse event between the two groups during 24 weeks
Incidence of complications of liver cirrhosis (infection, etc.)	24 weeks	Incidence of complications of liver cirrhosis refers to the incidence rate of complications between the two groups during 24 weeks
Proportion of patients readmitted	24 weeks	Proportion of patients readmitted refers to the readmission rate within 24 weeks between the Intervention group and Control group
Changes in total bilirubin level	24 weeks	Changes in total bilirubin level refers to the changes of total bilirubin at 24 week compared to baseline between the Intervention group and Control group.
Changes in alanine aminotransferase level	24 weeks	Changes in alanine aminotransferase level refers to the changes of alanine aminotransferase at 24 week compared to baseline between the Intervention group and Control group.
Changes in albumin level	24 weeks	Changes in albumin level refers to the changes of albumin at 24 week compared to baseline between the Intervention group and Control group.
Changes in prothrombin time level	24 weeks	Changes in prothrombin time level refers to the changes of prothrombin time at 24 week compared to baseline between the Intervention group and Control group.
Changes in international normalized ratio level	24 weeks	Changes in international normalized ratio level refers to the changes of international normalized ratio at 24 week compared to baseline between the Intervention group and Control group.

Trial Locations

Locations (1)

Department of infectious disease, Tongji Hospital; 🇨🇳 Wuhan, Hubei, China