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Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

RecruitingPhase 3Ages 18 Years - 75 YearsAllWuhan Createrna Science and Technology Co., Ltd
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In plain words

What the trial is, and whether it could suit you

The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Male and female participants โ‰ฅ 18 years of age and BMI โ‰ฅ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size โ‰ฅ 10%. 2. Mean hemoglobin level \<100 g/L at screening. 3. LDH \> 1.5 x Upper Limit of Normal (ULN) at screening. 4. 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: 1. Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L. 2. History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus. 3. Known or suspected hereditary complement deficiency. 4. Previous bone marrow or hematopoietic stem cell transplantation. 5. Previous splenectomy. 6. 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.
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What it tests

  • MY008211A tablets
  • Eculizumab Injection
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Where

2 sites
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, China
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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