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A study of the efficacy and safety of HRS-5965 capsules compared to eculizumab for 24 weeks in patients with PNH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HRS-5965 capsule | Experimental |
| |
| Eculizumab Injection | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HRS-5965 capsule | Drug | HRS-5965 capsule for 24 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with the hemoglobin levels are ≥ 12 g/dL at least on three out of four measurements in the absence of red blood cell transfusions | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with the change from baseline in hemoglobin is ≥ 2 g/dL at least on three out of four measurements in the absence of red blood cell transfusions | 24 weeks | |
| Proportion of subjects who absence of administration of red blood cell transfusions |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100730 | China | ||
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| Eculizumab Injection |
| Drug |
Eculizumab Injection for 24 weeks |
|
| 24 weeks |
| Mean change from baseline in hemoglobin | 24 weeks |
| Mean percent change from baseline in LDH levels | 24 weeks |
| Mean change from baseline in reticulocyte counts | 24 weeks |
| Mean change from baseline in FACIT-Fatigue scores | 24 weeks |
| The Blood Disease Hospital of the Chinese Academy of Medical Sciences |
| Tianjin |
| Tianjin Municipality |
| 300020 |
| China |
| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009190 | Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| C481642 | eculizumab |
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