Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

  • STATUS
    Recruiting
  • End date
    Dec 31, 2022
  • participants needed
    150
  • sponsor
    Tongji Hospital
Updated on 16 June 2021
platelet count
liver disease
cirrhosis
avatrombopag

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.

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 50~10010^9/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.

Details
Condition Thrombocytopenia, Hepatic Insufficiency, Thrombocytopenia and Thrombocytopenia Prevention, Hepatic Failure, Liver Failure, Decompensated Cirrhosis
Treatment Standard Medical Treatment, Avatrombopag
Clinical Study IdentifierNCT04906083
SponsorTongji Hospital
Last Modified on16 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women greater than or equal to 18 years of age
Baseline platelet count <5010^9/L
End-stage liver disease, including acute-on-chronic liver failure, acute decompensation of liver cirrhosis, chronic liver failure
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
Subject is able to understand the study and willing to follow the protocol and sign informed consent voluntarily before Baseline Visit
Subject meet the criteria according to the opinion of the researchers

Exclusion Criteria

Subject has a history of arterial or venous thrombosis within the previous 6 months of baseline
Known portal vein blood flow velocity rate <10 cm/second or previous occurrence of a portal vein thrombosis within 6 months of Baseline
Known any history of primary blood (e.g, immune thrombocytopenia, myelodysplastic syndrome, aplastic anemia)
Subject has a known medical history of genetic prothrombotic syndromes (e.g, Factor V Leiden prothrombin G20210A, antithrombin III (AT III) deficiency)
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)
Female subjects who are lactating or pregnant at the Baseline Visit (as documented by a positive serum beta-human chorionic gonadotropin [-hCG] test with a minimum sensitivity of 25 IU/L or equivalent units of -hCG) or are planning to become pregnant during the study
The subject has a hypersensitivity to Avatrombopag or any of its excipients
Subjects with drug-induced thrombocytopenia
Subjects whose Life expectation 6 months
Subject with a current malignancy
Subjects with HIV infection
At screening, active infection was not effectively controlled by systemic antibiotic therapy
The Investigator believe that any accompanying medical history may affect the safety of the subjects to complete the study
The Investigator believe that there are any other factors that are not suitable for inclusion or affect participation or completion of the study
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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