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
Condition(s) studied
Paroxysmal Nocturnal Hemoglobinuria, PNH
Investigational drug(s) / intervention(s)
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
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
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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