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NCT05886244CompletedPhase 3

Eculizumab in Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

Open-Label, Multicenter Study to Assess the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Complement Inhibitor Treatment Naïve Adult Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) in China

Source: ClinicalTrials.gov · Last updated 1 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
25 (actual)
First submitted
24 May 2023
Start date
5 Jul 2023
Primary completion date
14 Apr 2025
Lead sponsor
Alexion Pharmaceuticals, Inc.
NCT number
NCT05886244

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 25
  • From 5 Jul 2023 to the primary completion date, 14 Apr 2025
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Meningitidis infection or unresolved meningococcal disease
  • Significant bone marrow failure
  • Other significant systemic diseases that might have impact on efficacy and safety assessment

Who the study is looking for

  • Adult C5 inhibitor naïve PNH patients (age\>=18), which is confirmed by flow cytometry evaluation
  • Must be vaccinated against N meningitidis

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
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Coordinator of this site? Confirm its status
BeijingChinaUnknown status
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Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
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Coordinator of this site? Confirm its status
NantongChinaUnknown status
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Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
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Coordinator of this site? Confirm its status
TianjinChinaUnknown status
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Coordinator of this site? Confirm its status
WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.