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
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Condition or disease |
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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 |
Actual Primary Completion Date : | May 2012 |
Actual Study Completion Date : | July 2012 |

- Change in platelet count from baseline [ Time Frame: 26 weeks ]

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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 |
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

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