RecruitingPhase 2NCT06838949

A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP

A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary Immune Thrombocytopenia


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

80 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.


Eligibility

Min Age: 60 Years

Inclusion Criteria8

  • 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 Criteria16

  • 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.

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Interventions

DRUGherombopag olamine tablets

The patient received herombopag 5mg/d at the beginning of the day, was orally taken on an empty stomach in the morning, and could eat 2 hours after taking the drug, once a day for 24 weeks. Investigators will adjust the dosage of herombopag once a week according to the platelet count, with a maximum dosage of 7.5 mg per day. Efficacy and safety were evaluated once a week.


Locations(1)

Chinese academy of medical science and blood disease hospital

Tianjin, China

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NCT06838949


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