An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Alexion Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01194973

First received: August 31, 2010

Last updated: November 6, 2012

Last verified: October 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	August 31, 2010
Last Updated Date	November 6, 2012
Start Date ^ICMJE	July 2010
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 2, 2010)	Proportion of patients with complete TMA response. [ Time Frame: includes 26 weeks for the primary endpoint analysis with a possibility of continued treatment if patient continues to benefit from treatment for up to 2 years or until marketing approval for this indication. ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01194973 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome
Official Title ^ICMJE	An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome
Brief Summary	The record Primary purpose is to assess the efficacy of eculizumab in adult patients with aHUS to control TMA as characterized by thrombocytopenia, hemolysis and renal impairment.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Atypical Hemolytic-Uremic Syndrome
Intervention ^ICMJE	Drug: Eculizumab Eculizumab 600 mg, 900 mg or 1200 mg will be administered intravenously.
Study Arm (s)	single Intervention: Drug: Eculizumab
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 ^ICMJE	Active, not recruiting
Enrollment ^ICMJE	41
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion: Patient must be willing and able to give written informed consent. Patient's age > 18 years. Patients exhibit thrombocytopenia, hemolysis and elevated Serum Creatinine. Exclusion: Chronic dialysis. Prior eculizumab use or hypersensitivity to eculizumab, to murine proteins or to one of the excipients.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01194973
Other Study ID Numbers ^ICMJE	C10-004
Has Data Monitoring Committee	Not Provided
Responsible Party	Alexion Pharmaceuticals
Study Sponsor ^ICMJE	Alexion Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alexion Pharmaceuticals
Verification Date	October 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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