NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

CompletedPhase 3

Sponsor: Alexion Pharmaceuticals, Inc.

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Interventions: Eculizumab

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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:

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

Locations (7)

Beijing, China
Hangzhou, China
Nantong, China
Shanghai, China
Tianjin, China
Tianjin, China
Wuhan, China