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

December 21, 2012 updated by: Alexion Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Matsumoto, Japan
        • Shinshu University School of Medicine
      • Tokyo, Japan
        • Tokyo Medical and Dental University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The two identified Japanese patients with aHUS for which eculizumab treatment was initiated in 2011

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in platelet count from baseline
Time Frame: 26 weeks
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 21, 2012

First Posted (ESTIMATE)

December 24, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 24, 2012

Last Update Submitted That Met QC Criteria

December 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C11-004J

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)

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