To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients
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
1 other identifier
observational
2
1 country
2
Brief Summary
This protocol is intended to formally collect data on the treatment of aHUS with eculizumab in Japanese patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2012
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 4, 2012
CompletedFirst Posted
Study publicly available on registry
December 24, 2012
CompletedDecember 24, 2012
February 1, 2012
Same day
December 4, 2012
December 21, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Change in platelet count from baseline
26 weeks
Eligibility Criteria
The two identified Japanese patients with aHUS for which eculizumab treatment was initiated in 2011
You may qualify if:
- 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
You may not qualify if:
- Not Applicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shinshu University School of Medicine
Matsumoto, Japan
Tokyo Medical and Dental University
Tokyo, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2012
First Posted
December 24, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2012
Study Completion
July 1, 2012
Last Updated
December 24, 2012
Record last verified: 2012-02