Status:
ACTIVE_NOT_RECRUITING
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adults Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
PNH
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to evaluate the efficacy of ravulizumab in adult participants with PNH.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Adult C5 inhibitor naive PNH patients (age\>=18), which is confirmed by flow cytometry evaluation.
- Must be vaccinated againast N meningitidis.
- Exclusion Criteria
- Meningitidis infection or unresolved meningococcal disease
- History of bone marrow transplantation
- Other significant systemic diseases that might have impact on efficacy and safety assessment
Exclusion
Key Trial Info
Start Date :
October 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06578949
Start Date
October 10 2024
End Date
December 26 2025
Last Update
November 18 2025
Active Locations (8)
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1
Research Site
Beijing, China, CN-100730
2
Research Site
Guangzhou, China, 510100
3
Research Site
Hangzhou, China, 310003
4
Research Site
Nantong, China, 226001