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

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

Completed

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Key information

Conditions

Atypical Hemolytic Uremic Syndrome (aHUS) Anemia Anemia, Hemolytic Atypical Hemolytic Uremic Syndrome Blood Platelet Disorders Cytopenia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Hemolytic-Uremic Syndrome Kidney Diseases Male Urogenital Diseases Thrombocytopenia Thrombotic Microangiopathies Uremia Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Shinshu University School of Medicine, Matsumoto, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
Eculizumab treatment initiated as personal importation for aHUS in 201

Exclusion criteria

Not Applicable

Treatment and study plan

Primary outcomes

Change in platelet count from baseline

Time frame: 26 weeks

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2012
Primary completion: 2012
Study completion: 2012
First posted: Dec 24, 2012
Registry last updated: Dec 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed