Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

Last updated: June 3, 2021
Sponsor: Tongji Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Dysfunctional Uterine Bleeding

Liver Failure

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT04906083
TJ20210517
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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, acutedecompensation of liver cirrhosis, chronic liver failure;
  4. Women of childbearing potential must agree to use a highly effective method ofcontraception from the beginning of Baseline Visit until the end of treatment (includes implantable contraception, injectable contraception, hormonal combinationcontraception [including vaginal rings], intra-uterine devices or vasectomy). Thebarrier contraception with or without spermicide alone, double barrier contraceptionand oral contraceptives are inadequate;
  5. Subject is able to understand the study and willing to follow the protocol and signinformed consent voluntarily before Baseline Visit;
  6. Subject meet the criteria according to the opinion of the researchers.

Exclusion

Exclusion Criteria:

  1. Subject has a history of arterial or venous thrombosis within the previous 6 months ofbaseline;
  2. Known portal vein blood flow velocity rate <10 cm/second or previous occurrence of aportal vein thrombosis within 6 months of Baseline;
  3. Known any history of primary blood (e.g, immune thrombocytopenia, myelodysplasticsyndrome, aplastic anemia);
  4. Subject has a known medical history of genetic prothrombotic syndromes (e.g, Factor VLeiden prothrombin G20210A, antithrombin III (AT III) deficiency);
  5. Subject has a recent history (within the previous 6 months) of significantcardiovascular diseases (e.g., exacerbation of congestive heart failure, arrhythmiasknown to increase the risk of thromboembolic events [e.g. atrial fibrillation],coronary or peripheral artery stent placement or angioplasty, and coronary orperipheral artery bypass grafting);
  6. Female subjects who are lactating or pregnant at the Baseline Visit (as documented bya positive serum beta-human chorionic gonadotropin [β-hCG] test with a minimumsensitivity of 25 IU/L or equivalent units of β-hCG) or are planning to becomepregnant 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 antibiotictherapy;
  13. The Investigator believe that any accompanying medical history may affect the safetyof the subjects to complete the study;
  14. The Investigator believe that there are any other factors that are not suitable forinclusion or affect participation or completion of the study;
  15. Subject is enrolled in another clinical study with any investigational drug or devicewithin previous 30 days of the Baseline Visit, but are allowed to participate inobservational studies.

Study Design

Total Participants: 150
Study Start date:
February 01, 2021
Estimated Completion Date:
December 31, 2022

Study 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.

Connect with a study center

  • Department of infectious disease, Tongji Hospital

    Wuhan, Hubei 430030
    China

    Active - Recruiting

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