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

NCT06838949 | Recruiting Phase 2 DMC

• 1 other identifier: IIT2023054
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Herombopag

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Proportion of patients with platelet count ≥50×109/L

  8 weeks

• Proportion of patients with platelet count ≥100×109/L

  8 weeks

• Duration from treatment initiation to platelet count ≥30×10^9/L and ≥50×10^9/L

  24 weeks

• Sustained response at 24 weeks of treatment

  24 weeks

• The change in bleeding score before treatment and 8 weeks after treatment assessed using the world health organization (WHO) bleeding scale

  8 weeks

Study Arms (1)

Herombopag

EXPERIMENTAL

Herombopag 2.5mg per tablet

Drug: herombopag olamine tablets

Interventions

herombopag olamine tablets 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.

Herombopag

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Chinese academy of medical science and blood disease hospital

Tianjin, China

RECRUITING

Study Officials

• Yunfei Chen

  Chinese Academy of Medical Science and Blood Disease Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunfei Chen

CONTACT

+8618502220788; chenyunfei@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2025
• First Posted: February 21, 2025
• Study Start: March 3, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)