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Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

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 in PNH patients with residual anemia despite treatment with anti-C5 antibody.

Sign in to get the eligibility rules as simple questions to take to your doctor.

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. Stable regimen of anti-C5 antibody treatment for at least 6 months before treatment, and Hb was still \< 100 g/L. 3. The average hemoglobin level of at least two tests in 4 months before screening \< 100 g/L. 4. The average hemoglobin level of two tests in the central laboratory during screening \< 100 g/L. 5. 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
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Where

1 site
Peking Union Medical College Hospital (PUMCH).
Beijing, 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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