Avatrombopag in Primary Immune Thrombocytopenia (ITP) in Adults

  • STATUS
    Recruiting
  • days left to enroll
    69
  • participants needed
    20
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
Updated on 28 May 2021

Summary

This single-center study aims to study the efficacy and safety of avatrombopag in Chinese adult ITP patients. This study will be conducted in adult ITP patients who had not responded to eltrombopag or rhTPO in the previous treatment .

Description

The primary objective of this study was to evaluate the efficacy and safety of avatrombopag in adult ITP patients who had not responded to eltrombopag or rhTPO in the previous treatment.

20 eligible subjects will be enroll ed in this study.The dose will be adjusted according to the subject platelet count during the period from week 1 to week 8.

Details
Condition Primary Immune Thrombocytopenic Purpura
Treatment Avatrombopag
Clinical Study IdentifierNCT04890041
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on28 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women greater than or equal to 18 years of age
Participants diagnosed with chronic primary immune thrombocytopenia (greater than or equal to 12 months duration) and an average of 2 platelet counts < 30x10^9/L at least 7 days, do not have evidence of other causes of thrombocytopenia (e.g., pseudothrombocytopenia, myeloid fibrosis). The physical exam should not suggest any other diseases which may cause thrombocytopenia other than ITP
Previous treatment with Eltrombopag or rhTPO was ineffective (platelet count < 30x10^9/L after treatment, or platelet count increased less than twice the baseline value, or bleeding)
Prothrombin time/International Normalized Ratio and activated partial thromboplastin time must have been within 80% to 120% of the normal range with no history of hypercoagulable state
Good compliance

Exclusion Criteria

Patients diagnosed with secondary immune thrombocytopenia or a history of systemic lupus erythematosus and antiphospholipid antibody syndrome
A history of myelodysplastic syndrome (MDS), lymphoproliferative disease, myelodysplastic tumor, and leukemia
A history of arterial or venous thrombosis (stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism) within 3 months before screening, and the following 2 or more risk factors: including estrogen hormone replacement therapy or contraceptive therapy, smoking, diabetes, hypercholesterolemia, high blood pressure medications, cancer or any other family history of arterial or venous thrombosis, or patients who were taking anticoagulants or antiplatelet drugs at the beginning of the screening
Participants with a history of significant cardiovascular disease (e.g., congestive heart failure [CHF] New York Heart Association Grade III, arrhythmia known to increase the risk of thromboembolic events [e.g., atrial fibrillation], coronary artery stent placement, angioplasty, coronary artery bypass grafting)
Hereditary prethrombotic syndromes (e.g., thrombin factor V Leiden mutation, prothrombin G20210A mutation, or hereditary antithrombin (ATIII) deficiency)
Participants with concurrent malignant tumor diseases
Blood creatinine >1.2 times the upper limit of normal value (ULN)
Participants with known allergy to avatrombopag or its excipients
Women who are pregnant or who intend to become pregnant in the near future are excluded
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