Eculizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria (PNH) in China - Soliris

Study identifier:D7414C00001

ClinicalTrials.gov identifier:NCT05886244

EudraCT identifier:N/A

CTIS identifier:N/A

Recruitment Complete

Official Title

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

Medical condition

paroxysmal nocturnal hemoglobinuria

Phase

Phase 3

Healthy volunteers

No

Study drug

Eculizumab

Sex

All

Actual Enrollment

15

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 05 Jul 2023
Estimated Primary Completion Date: 27 Mar 2025
Estimated Study Completion Date: 27 Mar 2025

Study design

Allocation: N/A
Endpoint Classification: -
Intervention Model: Single Group Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2024 by Alexion Pharmaceuticals, Inc.

Sponsors

Alexion Pharmaceuticals, Inc.

Collaborators

AstraZeneca

Inclusion and exclusion criteria