Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
Recruiting now · Phase 3
Conditions studied: Paroxysmal Nocturnal Haemoglobinuria (PNH)
In brief
The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.
Key facts
- Study ID
- NCT06932744
- Run by
- Wuhan Createrna Science and Technology Co., Ltd
- People needed
- 66
- Starts
- 2024-08-30
- Expected to finish
- 2025-12-30
- Last updated by the study team
- 2025-05-09
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients with reticulocytes <100x10\^9/L; platelets <30x10\^9/L; neutrophils <0.5x10\^9/L.
- History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
- Known or suspected hereditary complement deficiency.
- Previous bone marrow or hematopoietic stem cell transplantation.
- Previous splenectomy.
- A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
Where it is running
- Chinese Academy of Medical Sciences Hematology Hospital — Tianjin, Tianjin Municipality, China (enrolling)
- Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China
Full record on ClinicalTrials.gov
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