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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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
 (submitted: December 21, 2012)
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 21, 2012)
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:

  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

Sex/Gender
Sexes Eligible for Study: All
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