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

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

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

Study Overview

• Status: Recruiting
• Conditions: Herombopag
• Intervention / Treatment: Drug: herombopag olamine tablets

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yunfei Chen; Phone Number: +8618502220788; Email: chenyunfei@ihcams.ac.cn

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Chinese Academy of Medical Science and Blood Disease Hospital
    • Contact: Yunfei Chen; Phone Number: +8618502220788; Email: chenyunfei@ihcams.ac.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Herombopag; Herombopag 2.5mg per tablet

Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with platelet count ≥30×109/L	Proportion of subjects with a platelet count ≥ 30 × 10^9/L and at least twice the baseline platelet count without bleeding at week 8	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with platelet count ≥50×109/L	Proportion of patients with platelet count ≥50×109/L within 8 weeks of treatment	8 weeks
Proportion of patients with platelet count ≥100×109/L	Proportion of patients who achieved CR within 8 weeks of treatment	8 weeks
Duration from treatment initiation to platelet count ≥30×10^9/L and ≥50×10^9/L	The time of first Platelet≥30×109/L and ≥50×109/L	24 weeks
Sustained response at 24 weeks of treatment	Sustained response at 24 weeks of treatment defined as 8 weeks after the last visit, at least 6 visits with platelets ≥30×109/L, greater than 2 times of baseline, and no bleeding	24 weeks
The change in bleeding score before treatment and 8 weeks after treatment assessed using the world health organization (WHO) bleeding scale	The change in bleeding score before treatment and 8 weeks after treatment according to the reported World Health Organization's Bleeding Scale. The WHO Bleeding Scale is a measure of bleeding severity with the following grades: grade 0 = no bleeding, grade 1= petechiae, grade 2= mild blood loss, grade 3 = gross blood loss, and grade 4 = debilitating blood loss.	8 weeks
Emergency treatment	The proportion of subjects who received emergency treatment within 8 weeks and during the entire study period.	8 weeks
incidence of treatment-emergent Adverse Events and TRAE	Incidence, severity, and relationship of treatment emergent adverse events after treatment as assessed by CTCAE v5.0	24 weeks

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China
• Investigators: Principal Investigator: Yunfei Chen, Chinese Academy of Medical Science and Blood Disease Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 21, 2025
• First Submitted That Met QC Criteria: February 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: IIT2023054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No