Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of HSK39297 tablets compared to eculizumab in Patients with PNH who Are Naive to Complement Inhibitor Therapy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK39297 tablets | Experimental |
| |
| Eculizumab Injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK39297 tablets | Drug | 200mg QD for 24 weeks |
| |
| Eculizumab Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving hemoglobin levels ≥ 12 g/dL at least on three out of four measurements in the absence of red blood cell transfusions | Between Week 18 and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with increase in hemoglobin levels from baseline of ≥20 g/L at least on three out of four measurements in the absence of red blood cell transfusions | Between Week 18 and Week 24 | |
| Proportion of participants who did not receive blood transfusion. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | 210029 | China | ||
| The First Affiliated Hospital, College of Medicine, Zhejiang University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Eculizumab Injection for 24 weeks |
|
| Between Week 2 and Week 24 |
| Change from baseline in hemoglobin | Baseline, week 18 to 24 |
| Change From Baseline in Reticulocyte Count | Baseline, week 18 to 24 |
| Percent change from baseline in LDH | Baseline, week 18 to 24 |
| Change from baseline in FACIT-Fatigue score | Baseline, week 18 to 24 |
| Rate of breakthrough hemolysis (BTH) | 24 weeks |
| Proportion of participants with Major Adverse Vascular Events (MAVEs) | 24 weeks |
| Hangzhou |
| Zhejiang |
| 310003 |
| China |
| ID | Term |
|---|---|
| C481642 | eculizumab |
Not provided
Not provided
Not provided