Status:
RECRUITING
Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
Lead Sponsor:
Wuhan Createrna Science and Technology Co., Ltd
Conditions:
Paroxysmal Nocturnal Haemoglobinuria (PNH)
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.
Detailed Description
This is a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this study is to determine whether MY008211A compared to eculizumab is efficacious an...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 30 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06932744
Start Date
August 30 2024
End Date
December 30 2025
Last Update
May 9 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100032
2
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, Tianjin Municipality, China, 300020