A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
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Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Institute of Hematology & Blood Diseases Hospital, China
- Trial code
- NCT06838949
- Record updated
- 13 March 2025
- Original description
The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.Read full original descriptionShow less
A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary Immune Thrombocytopenia
The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.
Inclusion: 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.
Exclusion: Patients who did not respond to previous treatment with herombopag; Receive TPO-RA medication within 2 weeks prior to treatment; 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; 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; There are severe active bleeding symptoms, such as gastrointestinal bleeding, intracranial bleeding, etc; Positive anti-human immunodeficiency virus antibody or anti-treponema pallidum specific antibody; Hepatitis virus positive, such as HBV, HCV, etc; A history of cirrhosis; Have an active infection that is difficult to control; Have a history of or accompanied by malignant tumors; Any other conditions that the investigator determines are not suitable for participation in the study; 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; 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; Bone marrow reticulum fiber staining (MF) ≥2 grade; Pregnant or lactating women.