Study of Herombopag Safety and Effectiveness for Treating Elderly Patients with Primary Immune Thrombocytopenia

What this Trial Is About

Researchers are studying the use of herombopag to help elderly patients with immune thrombocytopenia ITP, a condition that affects platelet levels in the blood. This phase 2 clinical trial focuses on patients aged 60 years and older to evaluate how well herombopag works and how safe it is for treating this condition in older adults. The study is designed as a single-arm, prospective trial involving 80 participants. Participants will take herombopag tablets starting at 5 mg once daily on an empty stomach, with the possibility to eat two hours afterward. The treatment lasts for 24 weeks, and the dosage may be adjusted weekly based on platelet counts, with a maximum of 7.5 mg per day. If there is no response after 8 weeks, patients may be advised to stop treatment but will continue safety monitoring for an additional 4 weeks. Treatment continues unless toxicity, disease progression, withdrawal of consent, or other criteria require stopping. Throughout the study, participants will have weekly blood tests to monitor platelet levels and overall safety, including vital signs and lab tests. Researchers will assess treatment effects at 8 weeks and 24 weeks, including platelet count improvements and bleeding symptoms. After treatment ends, a 4-week safety follow-up visit is conducted. The study aims to measure how many patients reach target platelet levels and track any adverse effects experienced during the study period.

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