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

ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) Clinical Trial

Official title:

A Research Study to Describe the Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS). An Assessment of Two Case Studies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01755429
• Other study ID #: C11-004J
• Status: Completed
• Phase: N/A
• First received: December 4, 2012
• Last updated: December 21, 2012
• Start date: May 2012
• Est. completion date: July 2012

Study information

• Verified date: February 2012
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)
• Azotemia
• Hemolysis
• Hemolytic-Uremic Syndrome

Locations

Country	Name	City	State
Japan	Shinshu University School of Medicine	Matsumoto
Japan	Tokyo Medical and Dental University	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in platelet count from baseline		26 weeks	Yes