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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Alexion Pharmaceuticals.
Recruitment status was  Active, not recruiting
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
  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:


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:

  1. Patient must be willing and able to give written informed consent.
  2. Patient's age > 18 years.
  3. Patients exhibit thrombocytopenia, hemolysis and elevated Serum Creatinine.

Exclusion:

  1. Chronic dialysis.
  2. Prior eculizumab use or hypersensitivity to eculizumab, to murine proteins or to one of the excipients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Thrombocytopenia
Syndrome
Hemolysis
Azotemia
Hemolytic-Uremic Syndrome
Disease
Pathologic Processes
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombotic Microangiopathies
Blood Platelet Disorders

ClinicalTrials.gov processed this record on September 29, 2014