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

Last updated: March 11, 2025
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

herombopag olamine tablets

Clinical Study ID

NCT06838949
IIT2023054
  • Ages > 60
  • All Genders

Study Summary

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

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

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: herombopag olamine tablets
Phase: 2
Study Start date:
March 03, 2025
Estimated Completion Date:
December 31, 2027

Study Description

This is a single-arm, prospective clinical study to evaluate the efficacy and safety of herombopag in the treatment of elderly patients with ITP. The study will include 80 patients. Screening of patients will be 2 weeks after the longest period, to enter after the treatment period, accept the herombopag 5 mg, once daily, on an empty stomach, oral medication can be eating only 2 hours, and 24 weeks of treatment, and adjust the dosage according to the platelet count. If patients do not respond to treatment after 8 weeks, it is recommended to withdraw from the study and continue safety visits for 4 weeks. During treatment, the patient continues treatment until the investigator assesses the occurrence of intolerable toxicity, disease progression, withdrawal of informed consent, or other discontinuation criteria specified in the protocol (whichever occurs first). Follow-up treatment for patients who withdraw from treatment due to safety or ineffectiveness is determined by the investigator according to clinical practice. Safety assessment during treatment, including vital signs, physical examination, laboratory examination, etc.; Check your blood routine at least once a week. A 4-week safety visit was performed after the final treatment.

Connect with a study center

  • Chinese academy of medical science and blood disease hospital

    Tianjin,
    China

    Active - Recruiting

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