Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adults Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH)
NCT ID: NCT06578949
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
18 participants
INTERVENTIONAL
2024-10-10
2025-12-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ravulizumab
During the Primary Treatment Period, participants will receive a weight-based loading dose of ravulizumab on Day 1 followed by weight-based maintenance dose of ravulizumab on Day 15 and once every 8 weeks (q8w) thereafter for a total of 26 weeks. On Day 183, all participants will enter a 32-week Extension Treatment Period and receive ravulizumab. Beginning on Day 183, participants will receive a maintenance dose of ravulizumab q8w for an additional 32 weeks.
Ravulizumab
Ravulizumab will be administered by intravenous (IV) infusion.
Interventions
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Ravulizumab
Ravulizumab will be administered by intravenous (IV) infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be vaccinated againast N meningitidis.
Exclusion Criteria
* History of bone marrow transplantation
* Other significant systemic diseases that might have impact on efficacy and safety assessment
18 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Research Site
Beijing, , China
Research Site
Guangzhou, , China
Research Site
Hangzhou, , China
Research Site
Nantong, , China
Research Site
Shanghai, , China
Research Site
Tianjin, , China
Research Site
Tianjin, , China
Research Site
Wuhan, , China
Countries
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Other Identifiers
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ALXN1210-PNH-323
Identifier Type: OTHER
Identifier Source: secondary_id
D9289C00008
Identifier Type: -
Identifier Source: org_study_id
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