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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

Study Description
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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 Design
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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
Actual Primary Completion Date : May 2012
Actual Study Completion Date : July 2012

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

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
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:

Not Applicable

Contacts and Locations
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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
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Japan
Shinshu University School of Medicine
Matsumoto, Japan
Tokyo Medical and Dental University
Tokyo, Japan
Sponsors and Collaborators
Alexion Pharmaceuticals
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01755429    
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:
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Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
Syndrome
Hemolysis
Disease
Pathologic Processes
Uremia
Kidney Diseases
 Urologic Diseases
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders