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Clinical Trials in China / NCT06932471
Recruiting Phase 3

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

NCT06932471 · tracked via the Priya Life Science China tracker
Sponsor
Wuhan Createrna Science and Technology Co., Ltd
Phase
Phase 3
Started
2024-08-30
Last updated
2025-05-09

Condition(s) studied

Paroxysmal Nocturnal Hemoglobinuria

Investigational drug(s) / intervention(s)

MY008211A tablets

MY008211A tablets: MY008211A tablets Participants will receive MY008211A at a dose of 400 mg orally b.i.d

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. 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%. 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking Union Medical College Hospital (PUMCH). Beijing Beijing Municipality Recruiting

More Wuhan Createrna Science and Technology Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06932471 on ClinicalTrials.gov ↗ ← All trials in China