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Clinical Trials in China / NCT06932744
Recruiting Phase 3

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

NCT06932744 · 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 Haemoglobinuria (PNH)

Investigational drug(s) / intervention(s)

MY008211A tabletsEculizumab Injection

MY008211A tablets: Participants will receive MY008211A at a dose of 400 mg orally b.i.d for 24 weeks

Eculizumab Injection: Eculizumab Injection for 24 weeks

Study summary

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

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. 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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences Beijing Beijing Municipality Not Yet Recruiting
Chinese Academy of Medical Sciences Hematology Hospital Tianjin Tianjin Municipality Recruiting

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

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 NCT06932744 on ClinicalTrials.gov ↗ ← All trials in China