Eculizumab in Pediatric and Adult Participants with Atypical Hemolytic Uremic Syndrome (aHUS) in China - Soliris

Study identifier:D7413C00001

ClinicalTrials.gov identifier:NCT05876351

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

Prospective, Single-Arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Eculizumab in Complement Inhibitor Treatment-Naïve Pediatric and Adult Participants with Atypical Hemolytic Uremic Syndrome (aHUS) in China

Medical condition

atypical hemolytic uremic

Phase

Phase 3

Healthy volunteers

No

Study drug

Eculizumab

Sex

All

Estimated Enrollment

25

Study type

Interventional

Age

n/a - n/a

Date

Study Start Date: 14 Jul 2023
Estimated Primary Completion Date: 31 Mar 2026
Estimated Study Completion Date: 31 Mar 2026

Study design

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

Verification:

Verified 01 Aug 2024 by Alexion Pharmaceuticals, Inc.

Sponsors

Alexion Pharmaceuticals, Inc.

Collaborators

AstraZeneca

Inclusion and exclusion criteria