avatrombopag in patients with end-stage liver disease and thrombocytopenia

Conditions: Liver Failure; Thrombocytopenia; Decompensated Cirrhosis

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.

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.

Eligibility criteria:
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.

Keywords: end-stage liver disease thrombocytopenia avatrombopag efficacy safety