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

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ClinicalTrials.gov Identifier: NCT01755429
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : December 24, 2012
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

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

Condition or disease
ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)

Study Type : Observational
Actual Enrollment : 2 participants
Time Perspective: Retrospective
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
Study Start Date : May 2012
Primary Completion Date : May 2012
Study Completion Date : July 2012





Primary Outcome Measures :
  1. Change in platelet count from baseline [ Time Frame: 26 weeks ]


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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The two identified Japanese patients with aHUS for which eculizumab treatment was initiated in 2011
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01755429


Locations
Japan
Shinshu University School of Medicine
Matsumoto, Japan
Tokyo Medical and Dental University
Tokyo, Japan
Sponsors and Collaborators
Alexion Pharmaceuticals

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01755429     History of Changes
Other Study ID Numbers: C11-004J
First Posted: December 24, 2012    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Syndrome
Hemolysis
Azotemia
Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
Disease
Pathologic Processes
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders