To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients
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| ClinicalTrials.gov Identifier: NCT01755429 |
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Recruitment Status :
Completed
First Posted : December 24, 2012
Last Update Posted : December 24, 2012
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Sponsor:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Alexion Pharmaceuticals
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date | December 4, 2012 | ||
| First Posted Date | December 24, 2012 | ||
| Last Update Posted Date | December 24, 2012 | ||
| Study Start Date | May 2012 | ||
| Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures |
Change in platelet count from baseline [ Time Frame: 26 weeks ] | ||
| Original Primary Outcome Measures | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures | Not Provided | ||
| Original Secondary Outcome Measures | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title | To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients | ||
| 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 | ||
| Brief Summary | This protocol is intended to formally collect data on the treatment of aHUS with eculizumab in Japanese patients. | ||
| Detailed Description | Not Provided | ||
| Study Type | Observational | ||
| Study Design | Time Perspective: Retrospective | ||
| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Non-Probability Sample | ||
| Study Population | The two identified Japanese patients with aHUS for which eculizumab treatment was initiated in 2011 | ||
| Condition | ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS) | ||
| Intervention | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Completed | ||
| Actual Enrollment |
2 | ||
| Original Actual Enrollment | Same as current | ||
| Actual Study Completion Date | July 2012 | ||
| Actual Primary Completion Date | May 2012 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: Not Applicable |
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||
| Accepts Healthy Volunteers | No | ||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries | Japan | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT01755429 | ||
| Other Study ID Numbers | C11-004J | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Alexion Pharmaceuticals | ||
| Study Sponsor | Alexion Pharmaceuticals | ||
| Collaborators | Not Provided | ||
| Investigators | Not Provided | ||
| PRS Account | Alexion Pharmaceuticals | ||
| Verification Date | February 2012 | ||