Phase
Condition
N/ATreatment
herombopag olamine tablets
Clinical Study ID
Ages > 60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients voluntarily participated in the study and signed informed consent;
Age ≥60 years old, gender unlimited;
ECOG PS ≤2;
Expected survival ≥6 months;
A definitive diagnosis of ITP, including newly diagnosed, chronic, and persistentITP;
PLT < 30×109/L for at least two consecutive times with an interval of at least 1 daybefore medication
Patients with laboratory test results meet the following criteria: a. alanineaminotransferase (ALT) 3.0 x or less normal limit (ULN), aspartate aminotransferase (AST) 3.0 x ULN or less; b. Serum total bilirubin ≤1.5×ULN; c. Serum creatinine ≤1.5×ULN;
The researchers determined that patients could be treated with hexapopal.
Exclusion
Exclusion Criteria:
Patients who did not respond to previous treatment with herombopag;
A history of allergy to thrombopoietin receptor agonist (TPO-RA) drugs;
Combined with other important organ dysfunction, such as liver and kidney failure,cardiac insufficiency, etc.
Secondary thrombocytopenia, such as rheumatic immune disease, chronic liver disease,hyperlienism, malignant hematologic disease, bone marrow hematopoietic exhaustiondisease (such as AA, MDS), hereditary thrombocytopenia, CVID, drug-inducedthrombocytopenia, etc.;
Receive TPO-RA medication within 2 weeks prior to treatment;
Non-steroidal anti-inflammatory drugs (aspirin, salicylate, etc.) and anticoagulants (warfarin, clopidogrel, etc.) should be taken during treatment, which have an impacton platelet function.
There are severe active bleeding symptoms, such as gastrointestinal bleeding,intracranial bleeding, etc.
Severe thrombotic disease, such as transient ischemic attack, myocardial infarction,pulmonary embolism, deep vein thrombosis, and disseminated intravascular coagulation (DIC), occurred within 6 months prior to the screening period;
Have a New York Heart Society (NYHA) Class 3 or 4 congestive heart failure, or havea history of NYHA Class 3/4 congestive heart failure with a left ejection fraction (LVEF) of < 45% within 4 weeks prior to treatment;
Positive anti-human immunodeficiency virus antibody or anti-treponema pallidumspecific antibody; Hepatitis virus positive, such as HBV, HCV, etc.
A history of cirrhosis;
Bone marrow reticulum fiber staining (MF) ≥2 grade;
Have an active infection that is difficult to control;
Have a history of or accompanied by malignant tumors;
Pregnant or lactating women;
Any other conditions that the investigator determines are not suitable forparticipation in the study.
Study Design
Study Description
Connect with a study center
Chinese academy of medical science and blood disease hospital
Tianjin,
ChinaActive - Recruiting
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