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

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

Sponsors

Lead sponsor: Alexion Pharmaceuticals

Source Alexion Pharmaceuticals
Brief Summary

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

Overall Status Completed
Start Date May 2012
Completion Date July 2012
Primary Completion Date May 2012
Study Type Observational
Primary Outcome
Measure Time Frame
Change in platelet count from baseline 26 weeks
Enrollment 2
Condition
Eligibility

Sampling method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Location
facility
Shinshu University School of Medicine | Matsumoto, Japan
Tokyo Medical and Dental University | Tokyo, Japan
Location Countries

Japan

Verification Date

February 2012

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Study Design Info

Time perspective: Retrospective

Source: ClinicalTrials.gov