Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China
About the study
This is a Phase 3b, single-arm, open-label, multicenter study to evaluate the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of eculizumab in adult participants with paraxysmal noturnal hemoglobinuria (PNH) in China.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Adult C5 inhibitor naïve PNH patients (age>=18), which is confirmed by flow cytometry evaluation.
- Must be vaccinated against N meningitidis.
EXCLUSION CRITERIA
Exclusion Criteria:
- Meningitidis infection or unresolved meningococcal disease
- Significant bone marrow failure
- Other significant systemic diseases that might have impact on efficacy and safety assessment
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Paroxysmal Nocturnal Hemoglobinuria
Age (in years)
18+
Phase
PHASE3
Participants needed
25
Est. Completion Date
Apr 23, 2025
Treatment type
INTERVENTIONAL
Sponsor
Alexion Pharmaceuticals, Inc.
ClinicalTrials.gov identifier
NCT05886244
Study number
D7414C00001
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