Evaluating Herombopag for treating elderly patients with ITP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical study aims to assess the efficacy and safety of Herombopag in elderly patients diagnosed with Immune Thrombocytopenic Purpura (ITP). It is a single-arm, prospective study involving 80 participants who will receive 5 mg of Herombopag daily for 24 weeks, with dosage adjustments based on platelet counts. Patients will be monitored for treatment response and safety, including regular laboratory tests and follow-up visits. If patients do not respond after 8 weeks, they may withdraw from the study while continuing safety assessments.

Why it matters

Who can join: the full rules

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 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 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 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's running

• Chinese academy of medical science and blood disease hospital
  Tianjin, China Recruiting

Study contacts

• Principal investigator: Yunfei Chen — Chinese Academy of Medical Science and Blood Disease Hospital
• Study coordinator: Yunfei Chen
• Email: chenyunfei@ihcams.ac.cn
• Phone: +8618502220788

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Multi-target drugs sequentially combine therapy in adults with newly diagnosed immune thrombocytopenia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.