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This study includes Part A and Part B. Part A is a dose-finding study for subjects with chronic liver disease-related thrombocytopenia scheduled for elective surgery. Part B is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy and safety of Herombopag compared to placebo in patients with chronic liver disease-related thrombocytopenia undergoing elective invasive surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group 1 | Experimental |
| |
| Treatment group 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herombopag tablets | Drug | Herombopag tablets; dose 1 or dose 2, for 5 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: CL/F | 0 minute to 5 days | |
| Part A: Vc/F | 0 minute to 5 days | |
| Part A: ka | 0 minute to 5 days | |
| Part A: Q/F | 0 minute to 5 days | |
| Part A: AUC0-tau | 0 minute to 5 days | |
| Part A: Cmax | 0 minute to 5 days | |
| Part A: Kin | 0 minute to 35 days | |
| Part A: Kout | 0 minute to 35 days | |
| Part A: Kdeg | 0 minute to 35 days | |
| Part A: Slope | 0 minute to 35 days | |
| The proportion of subjects whose platelet count is ≥50×10^9/L within 24 hours before surgery and has increased by ≥20×10^9/L from baseline, and who have not received platelet transfusion or other treatments to raise platelet levels before surgery | Part B | 0 minute to 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects with a platelet count of ≥50×10^9/L within 24 hours before surgery | 0 minute to 11 days | |
| The duration of time during the study when the platelet count remains ≥50×10^9/L | 0 minute to 35 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ting Zhang | Contact | +86 0518-82342973 | ting.zhang.tz89@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, affiliated with Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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Herombopag compared with placebo
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| Herombopag placebo tablets | Drug | Herombopag placebo tablets; dose 1 or dose 2, for 5 days |
|