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This is a multicenter, open-label study to evaluate the long-term safety, tolerability and efficacy of HSK39297. Adult patients with PNH who had previously received and completed HSK39297 study treatment will be included. Eligible subjects can maintain HSK39297 treatment until the end of the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK39297 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK39297 tablets | Drug | HSK39297 tablets until the end of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | through study completion,about 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving hemoglobin levels ≥ 12 g/dL in the absence of red blood cell transfusions | through study completion,about 2 years | |
| Change From Baseline in Hemoglobin in the absence of red blood cell transfusions | through study completion,about 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li | Contact | +8602867258840 | lifangq@haisco.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Recruiting | Nanjing | Jiangsu | China |
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| ID | Term |
|---|---|
| D006457 | Hemoglobinuria, Paroxysmal |
| ID | Term |
|---|---|
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Proportion of participants who remain free from transfusions | through study completion,about 2 years |
| Rate of breakthrough hemolysis (BTH) | through study completion,about 2 years |
| Proportion of participants with Major Adverse Vascular Events (MAVEs) | through study completion,about 2 years |
| D009190 |
| Myelodysplastic Syndromes |
| D001855 | Bone Marrow Diseases |