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Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia | Clinical Trials | Clareo Health

UNKNOWNPHASE4

Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

The Efficacy and Safety of Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia: A Multicenter, Prospective, Randomized Controlled Trial（EAST）

NCT04906083•Tongji Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;
+5 more criteria

Locations (1)

Department of infectious disease, Tongji Hospital

Wuhan, Hubei, China

Key Dates

Start Date

February 1, 2021

Primary Completion Date

December 31, 2022

Completion Date

December 31, 2022

Last Updated

June 7, 2021

Enrollment

150

ESTIMATED participants

Conditions

Liver FailureThrombocytopeniaDecompensated Cirrhosis

Interventions

Avatrombopag

DRUG

Standard medical treatment

DRUG

Contacts

Qin Ning, MD., PhD.

CONTACT

+8602783662391 qning@vip.sina.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 7, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

Inclusion Criteria

Exclusion Criteria

Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders

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