Actively Recruiting
Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
Led by Wuhan Createrna Science and Technology Co., Ltd · Updated on 2025-05-09
66
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.
CONDITIONS
Official Title
Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants aged 18 years or older with a body mass index of 18.0 kg/m2 or higher and a confirmed diagnosis of PNH with clone size 10% or greater
- Mean hemoglobin level less than 100 g/L at screening
- Lactate dehydrogenase (LDH) level greater than 1.5 times the upper limit of normal at screening
- Vaccination against Neisseria meningitidis infection before starting study treatment; vaccination against Streptococcus pneumoniae and Haemophilus influenzae if not previously received
You will not qualify if you...
- Reticulocyte count less than 100 x 10^9/L, platelet count less than 30 x 10^9/L, or neutrophil count less than 0.5 x 10^9/L
- History of recurrent invasive infections caused by encapsulated organisms such as meningococcus or pneumococcus
- Known or suspected hereditary complement deficiency
- Previous bone marrow or hematopoietic stem cell transplantation
- Previous splenectomy
- History of malignancy within 5 years before screening, except for cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100032
Not Yet Recruiting
2
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
W
Wuhan Createrna Science and Technology Co.,Ltd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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