Actively Recruiting
Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment
Led by Wuhan Createrna Science and Technology Co., Ltd · Updated on 2025-05-09
20
Participants Needed
1
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 in PNH patients with residual anemia despite treatment with anti-C5 antibody.
CONDITIONS
Official Title
Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female participants 18 years of age or older with a body mass index of 18.0 kg/m2 or higher and a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size 10% or greater
- Stable anti-C5 antibody treatment regimen for at least 6 months before study with hemoglobin less than 100 g/L
- Average hemoglobin level below 100 g/L from at least two tests in the 4 months before screening
- Average hemoglobin level below 100 g/L from two tests in the central laboratory during screening
- Vaccination against Neisseria meningitidis infection prior to starting study treatment; if not previously vaccinated, also vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections
You will not qualify if you...
- Reticulocytes below 100x10^9/L, platelets below 30x10^9/L, or neutrophils below 0.5x10^9/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 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: 1 location
1
Peking Union Medical College Hospital (PUMCH).
Beijing, Beijing Municipality, China, 100032
Actively Recruiting
Research Team
W
Wuhan Createrna Science and Technology Co.,Ltd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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