A study of the efficacy and safety of VSA012 Injection compared to eculizumab for 24 weeks in patients with PNH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
70
VSA012 Injection
Eculizumab injection
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Jilin
Jilin City, Changchun, China
Quanzhou
Quanzhou, Fujian, China
The proportion of patients with sustained hemoglobin levels ≥ 120 g/L among those without RBC transfusion (defined as no red blood cell infusion after W2 to W26).
Time frame: between Week 2 and Week 26
Proportion of participants achieving a sustained increase from baseline in hemoglobin levels of ≥ 20 g/L assessed among those without RBC transfusion (defined as no red blood cell infusion after W2 to W26).
Time frame: between Week 20 and Week 26
The proportion of patients with hemolysis controlled (defined as LDH < 1.5 ULN) among those without RBC transfusion
Time frame: between Week 20 and Week 26
Change (Expressed as Percentages) in Hb level from baseline
Time frame: between Week 20 and Week 26
The proportion of patients without RBC transfusion
Time frame: between Week 2 and Week 26
Change in reticulocyte count from baseline
Time frame: between Week 20 and Week 26
Change in Total bilirubin count from baseline
Time frame: between Week 20 and Week 26
Change in FACIT-F score from baseline
Time frame: between Week 20 and Week 26
The Clinical BTH Rate
Time frame: between Day 1 and Week 26
The Major Adverse Vascular Events Rate
Time frame: between Day 1 and Week 26
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Guangzhou
Guangzhou, Guangdong, China
Nanning
Nanning, Guangxi, China
Ha'erbin
Harbin, Heilongjiang, China
Zhengzhou
Zhengzhou, Henan, China
Wuhan
Wuhan, Hubei, China
Changsha
Changsha, Hunan, China
Nantong
Nantong, Jiangsu, China
...and 4 more locations
Incidence and severity of AEs
Time frame: between Day 1 and Week 26