Clinical trial NCT06838949: A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary ITP
Official title: A Clinical Study on the Efficacy and Safety of Herombopag in the Treatment of Senile Primary Immune Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Herombopag
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed 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.

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.

Primary outcomes:
measure: Proportion of patients with platelet count ≥30×109/L
timeFrame: 8 weeks
Secondary outcomes:
measure: Proportion of patients with platelet count ≥50×109/L
timeFrame: 8 weeks
measure: Proportion of patients with platelet count ≥100×109/L
timeFrame: 8 weeks
measure: Duration from treatment initiation to platelet count ≥30×10^9/L and ≥50×10^9/L
timeFrame: 24 weeks
measure: Sustained response at 24 weeks of treatment
timeFrame: 24 weeks
measure: The change in bleeding score before treatment and 8 weeks after treatment assessed using the world health organization (WHO) bleeding scale
timeFrame: 8 weeks
measure: Emergency treatment
timeFrame: 8 weeks
measure: incidence of treatment-emergent Adverse Events and TRAE
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Chinese academy of medical science and blood disease hospital
Study officials:
affiliation: Chinese Academy of Medical Science and Blood Disease Hospital
name: Yunfei Chen
role: PRINCIPAL_INVESTIGATOR
References: