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The objective of this study was to evaluate the efficacy and safety of Herombopag in the treatment of elderly patients with ITP.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Herombopag | Experimental | Herombopag 2.5mg per tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yunfei Chen | Contact | +8618502220788 | chenyunfei@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yunfei Chen | Chinese Academy of Medical Science and Blood Disease Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese academy of medical science and blood disease hospital | Recruiting | Tianjin | China |
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|
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 |