To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients

Completed

• Conditions: ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)

• Registration Number: NCT01755429
• Lead Sponsor: Alexion Pharmaceuticals, Inc.

Brief Summary

This protocol is intended to formally collect data on the treatment of aHUS with eculizumab in Japanese patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-02
• Study Start: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-07
• Study First Submitted: 2012-12-04
• Study First Submitted QC: 2012-12-21
• Last Update Submitted: 2012-12-21
• Study First Posted: 2012-12-24
• Last Update Posted: 2012-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

1. Patient and/or legal guardian must be willing and able to give written informed consent and id the patient is not an adult and able to read and write, the patient is willing to give written informed assent
2. Eculizumab treatment initiated as personal importation for aHUS in 201

Exclusion Criteria

Not Applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in platelet count from baseline	26 weeks

Trial Locations

Locations (2)

Shinshu University School of Medicine; 🇯🇵 Matsumoto, Japan

Tokyo Medical and Dental University; 🇯🇵 Tokyo, Japan