A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP
Recruiting now · Phase 2
Conditions studied: Herombopag
In brief
The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.
Key facts
- Study ID
- NCT06838949
- Run by
- Institute of Hematology & Blood Diseases Hospital, China
- People needed
- 80
- Starts
- 2025-03-03
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2025-03-13
Who can join
Age: 60 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 persistent ITP;
- PLT < 30×109/L for at least two consecutive times with an interval of at least 1 day before medication
- Patients with laboratory test results meet the following criteria: a. alanine aminotransferase (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.
You may not qualify if…
- 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 exhaustion disease (such as AA, MDS), hereditary thrombocytopenia, CVID, drug-induced thrombocytopenia, 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 impact on 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 have a 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 pallidum specific 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 for participation in the study.
Where it is running
- Chinese academy of medical science and blood disease hospital — Tianjin, China (enrolling)
Full record on ClinicalTrials.gov
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