Evaluating Herombopag for treating elderly patients with ITP

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

This study is testing if the medication Herombopag can help older patients with Immune Thrombocytopenic Purpura (ITP) improve their platelet counts and overall health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Locations: 1 site (Tianjin)
• Trial ID: NCT06838949 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are elderly patients aged 60 and above with a confirmed diagnosis of ITP and low platelet counts.

Not a fit: Patients who have previously not responded to Herombopag or have significant organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for elderly patients suffering from ITP, potentially improving their platelet counts and overall health.

How similar studies have performed: While this approach is being evaluated in this specific population, previous studies on Herombopag have shown promise in treating ITP, indicating potential for success.

Eligibility criteria

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 this trial is running

Tianjin

• 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

Conditions Herombopag