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

NCT ID: NCT06838949

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2027-12-31

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.

Conditions

Herombopag

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Herombopag

Herombopag 2.5mg per tablet

Group Type: EXPERIMENTAL

herombopag olamine tablets

Intervention Type: DRUG

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.

Interventions

herombopag 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yunfei Chen

Role: PRINCIPAL_INVESTIGATOR

Chinese Academy of Medical Science and Blood Disease Hospital

Locations

Chinese academy of medical science and blood disease hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yunfei Chen

Role: CONTACT

chenyunfei@ihcams.ac.cn

+8618502220788

Facility Contacts

Yunfei Chen

Role: primary

chenyunfei@ihcams.ac.cn

+8618502220788

Other Identifiers

IIT2023054

Identifier Type: -

Identifier Source: org_study_id