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Trial · Interventional

Status unknownPhase 4Registry data

Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

Overview

Status
Status unknown
Phase
Phase 4
Enrollment
150 participants (estimated)
Sponsor
Tongji Hospital · Other
Design
Randomized · Open label (no masking)
Countries
1 country

China

Start
1 Feb 2021
Primary completion
31 Dec 2022 (estimated)
Completion
31 Dec 2022 (estimated)
First posted
28 May 2021
Last update posted
7 Jun 2021
Conditions
Liver Failure · Thrombocytopenia · Decompensated Cirrhosis

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 4

    Avatrombopag in Patients With End-stage Liver Disease and Thrombocytopenia

    NCT04906083

    1 Feb 2021 to est. 31 Dec 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • AvatrombopagDrug
  • Standard medical treatmentDrug

Arms2

  • Experimental

    Intervention group

    Avatrombopag+Standard medical treatment

  • Other

    Control group

    Standard medical treatment

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Platelet count response time

    Time frame · 24 weeks

    Registry description

    Platelet count response time(PLT) refers to condition of PLT during 24 weeks between the Intervention group and Control group.

Secondary outcomes(9)
  1. Adverse Event (thrombotic events, bleeding events, etc.) incidence;

    Time frame · 24 weeks

    Registry description

    Adverse Event refers to the incidence rate of adverse event between the two groups during 24 weeks

  2. Incidence of complications of liver cirrhosis (infection, etc.)

    Time frame · 24 weeks

    Registry description

    Incidence of complications of liver cirrhosis refers to the incidence rate of complications between the two groups during 24 weeks

  3. Patients without platelet transfusion or rescue due to bleeding

    Time frame · 24 weeks

    Registry description

    Patients without platelet transfusion or rescue due to bleeding refers to the patients rate without platelet transfusion or rescue due to bleeding between the two groups at 24 week

  4. Proportion of patients readmitted

    Time frame · 24 weeks

    Registry description

    Proportion of patients readmitted refers to the readmission rate within 24 weeks between the Intervention group and Control group

  5. Changes in total bilirubin level

    Time frame · 24 weeks

    Registry description

    Changes in total bilirubin level refers to the changes of total bilirubin at 24 week compared to baseline between the Intervention group and Control group.

  6. Changes in alanine aminotransferase level

    Time frame · 24 weeks

    Registry description

    Changes in alanine aminotransferase level refers to the changes of alanine aminotransferase at 24 week compared to baseline between the Intervention group and Control group.

  7. Changes in albumin level

    Time frame · 24 weeks

    Registry description

    Changes in albumin level refers to the changes of albumin at 24 week compared to baseline between the Intervention group and Control group.

  8. Changes in prothrombin time level

    Time frame · 24 weeks

    Registry description

    Changes in prothrombin time level refers to the changes of prothrombin time at 24 week compared to baseline between the Intervention group and Control group.

  9. Changes in international normalized ratio level

    Time frame · 24 weeks

    Registry description

    Changes in international normalized ratio level refers to the changes of international normalized ratio at 24 week compared to baseline between the Intervention group and Control group.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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