A Multicenter, Randomized, Open-Label, Positive Controlled Phase III Study to Evaluate the Efficacy and Safety of VSA012 Injection in Participants With Paroxysmal Nocturnal Hemoglobinuria Who Are Naive to Complement Inhibitor Therapy
A study of the efficacy and safety of VSA012 Injection compared to eculizumab for 24 weeks in patients with PNH.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size≥10%.
* Mean hemoglobin level \<100 g/L at screening.
* LDH \> 1.5 x Upper Limit of Normal (ULN) at screening.
* Vaccination against Neisseria meningitidis infection is required prior to the
* start of study treatment. If not received previously, vaccination against
* Streptococcus pneumoniae and Haemophilus influenzae infections should be given.
Exclusion Criteria:
* Known or suspected hereditary or acquired complement deficiency;
* Presence or suspicion of a systemic active bacterial, viral, or fungal infection
* History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
* Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L.
* Positive of HIV, HBsAg or HCVAb.
* History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
* Previous splenectomy.
* A history of malignancy within 5 years before screening
Primary outcome measure(s)
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). — between Week 2 and Week 26
Trial sites (14)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
Beijing Municipality
Jilin
Jilin City
Changchun
Quanzhou
Quanzhou
Fujian
Guangzhou
Guangzhou
Guangdong
Nanning
Nanning
Guangxi
Ha'erbin
Harbin
Heilongjiang
Zhengzhou
Zhengzhou
Henan
Wuhan
Wuhan
Hubei
Changsha
Changsha
Hunan
Nantong
Nantong
Jiangsu
Xi'an
Xi’an
Shanxi
Chengdu
Chengdu
Sichuan
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin
Tianjin Municipality
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
More Bisirna Therapeutics (Suzhou) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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