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:
Alexion Pharmaceuticals
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Atypical Hemolytic-Uremic Syndrome |
Drug: Eculizumab |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome |
Resource links provided by NLM:
Genetics Home Reference related topics:
atypical hemolytic-uremic syndrome
Drug Information available for:
Eculizumab
U.S. FDA Resources
Further study details as provided by Alexion Pharmaceuticals:
Primary Outcome Measures:
- 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 ]
| Enrollment: | 41 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| single |
Drug: Eculizumab
Eculizumab 600 mg, 900 mg or 1200 mg will be administered intravenously.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194973
Locations
| United States, Massachusetts | |
| Burlington, Massachusetts, United States, 01805 | |
| United States, New Jersey | |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New York | |
| New York, New York, United States, 10032 | |
| United States, Ohio | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97210 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Alexion Pharmaceuticals
More Information
No publications provided
| Responsible Party: | Alexion Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01194973 History of Changes |
| Other Study ID Numbers: | C10-004 |
| Study First Received: | August 31, 2010 |
| Last Updated: | November 6, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Alexion Pharmaceuticals:
|
Atypical Hemolytic-Uremic Syndrome |
Additional relevant MeSH terms:
|
Hemolytic-Uremic Syndrome Azotemia Hemolysis Uremia Kidney Diseases Urologic Diseases Anemia, Hemolytic |
Anemia Hematologic Diseases Thrombotic Microangiopathies Thrombocytopenia Blood Platelet Disorders Pathologic Processes |
ClinicalTrials.gov processed this record on June 13, 2013