Status:
COMPLETED
A Real-world, Multi-center, Prospective, Observational Study for PNH in China
Lead Sponsor:
AstraZeneca
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
Brief Summary
As a rare disease listed in the First Catalogue of Rare Diseases in China (National Health Commission of the People's Republic of China, 2019), PNH is poorly studied in China subse-quently leading to ...
Detailed Description
Paroxysmal nocturnal hemoglobinuria (PNH) is an ultra-rare and life-threatening acquired disorder of the pluripotent hematopoietic stem cell and therefore can affect erythrocytes, leukocytes, thromboc...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Patients of any age;
- Diagnosed PNH with detected proportion of PNH clone cells of at least 1%;
- Patient or patient's family must be willing and able to give written informed consent.
- Exclusion Criteria
- Current or previous treatment with a non-eculizumab complement inhibitor;
- Patients in other PNH clinical trials.
- Unable to give written informed consent.
Exclusion
Key Trial Info
Start Date :
November 10 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 3 2025
Estimated Enrollment :
724 Patients enrolled
Trial Details
Trial ID
NCT06154512
Start Date
November 10 2023
End Date
December 3 2025
Last Update
December 18 2025
Active Locations (40)
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1
Research Site
Hefei, Anhui, China, 230002
2
Research Site
Beijing, Beijing Municipality, China, 100000
3
Research Site
Beijing, Beijing Municipality, China, 100044
4
Research Site
Guangzhou, Guangdong, China, 510080