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Clinical Trials in China / NCT07816237
Starting soon Phase 3

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

NCT07816237 · tracked via the Priya Life Science China tracker
Sponsor
Bisirna Therapeutics (Suzhou) Co., Ltd.
Phase
Phase 3
Started
2026-10-29
Last updated
2026-09-11

Condition(s) studied

Paroxysmal Nocturnal Hemoglobinuria, PNH

Investigational drug(s) / intervention(s)

VSA012Eculizumab (Soliris®)

VSA012: VSA012 Injection

Eculizumab (Soliris®): Eculizumab injection

Study summary

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)

Trial sites (14)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT07816237 on ClinicalTrials.gov ↗ ← All trials in China