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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Avatrombopag: PLT:30\~50×10\^9/L patients, 40 mg/d; PLT:\<30×10\^9/L patients, 60 mg/d.
Standard medical treatment included transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al.
Department of infectious disease, Tongji Hospital
Wuhan, Hubei, China
RECRUITINGPlatelet count response time
Platelet count response time(PLT) refers to condition of PLT during 24 weeks between the Intervention group and Control group.
Time frame: 24 weeks
Adverse Event (thrombotic events, bleeding events, etc.) incidence;
Adverse Event refers to the incidence rate of adverse event between the two groups during 24 weeks
Time frame: 24 weeks
Incidence of complications of liver cirrhosis (infection, etc.)
Incidence of complications of liver cirrhosis refers to the incidence rate of complications between the two groups during 24 weeks
Time frame: 24 weeks
Patients without platelet transfusion or rescue due to bleeding
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
Time frame: 24 weeks
Proportion of patients readmitted
Proportion of patients readmitted refers to the readmission rate within 24 weeks between the Intervention group and Control group
Time frame: 24 weeks
Changes in total bilirubin level
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.
Time frame: 24 weeks
Changes in alanine aminotransferase level
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.
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Time frame: 24 weeks
Changes in albumin level
Changes in albumin level refers to the changes of albumin at 24 week compared to baseline between the Intervention group and Control group.
Time frame: 24 weeks
Changes in prothrombin time level
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.
Time frame: 24 weeks
Changes in international normalized ratio level
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.
Time frame: 24 weeks