Status:
UNKNOWN
Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia
Lead Sponsor:
Tongji Hospital
Collaborating Sponsors:
Anhui Provincial Hospital
The First Affiliated Hospital of Nanchang University
Conditions:
Liver Failure
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Avatrom...
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,...
Eligibility Criteria
Inclusion
- Men and women greater than or equal to 18 years of age;
- Baseline platelet count \<50×10\^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
- 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 \[β-hCG\] test with a minimum sensitivity of 25 IU/L or equivalent units of β-hCG) or are planning to become pregnant during the study;
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04906083
Start Date
February 1 2021
End Date
December 31 2022
Last Update
June 7 2021
Active Locations (1)
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1
Department of infectious disease, Tongji Hospital
Wuhan, Hubei, China, 430030