Trial record 6 of 24 for:    "atypical hemolytic-uremic syndrome" OR "Hemolytic-Uremic Syndrome"

A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01770951
First received: November 13, 2012
Last updated: January 16, 2013
Last verified: August 2009
  Purpose

The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.


Condition
Atypical Hemolytic Uremic Syndrome (aHUS)

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • Overall safety and tolerability of eculizumab based on Adverse Events of Special Interest/Adverse Drug Reactions and Additional Adverse Events. [ Time Frame: Through 26 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess eculizumab treatment affect based on change in laboratory parameters (platelets, hemoglobin, LDH and parameters associated with renal function and intravascular hemolysis) and reduction of thrombotic microangiopathy (TMA). [ Time Frame: Through 26 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: August 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Male or female patients of any age who have been diagnosed with aHUS.

Criteria

Inclusion Criteria:

  1. Male or female patients of any age who have been diagnosed with aHUS.
  2. Received at least one dose of eculizumab for the treatment of aHUS between 2007 and 2009 outside of an Alexion sponsored controlled clinical trial.

Exclusion Criteria:

1. Patients who have participated or are currently participating in a controlled clinical trial of eculizumab

  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: NCT01770951

  Show 23 Study Locations
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

No publications provided

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01770951     History of Changes
Other Study ID Numbers: C09-001r
Study First Received: November 13, 2012
Last Updated: January 16, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014