Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Atypcial Hemolytic-Uremic Syndrome (aHUS) Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Alexion Pharmaceuticals
Sponsor:
Collaborator:
INC Research
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01522183
First received: January 18, 2012
Last updated: February 17, 2017
Last verified: February 2017
  Purpose
Post-marketing safety data on patients treated and untreated with eculizumab.

Condition
Atypical Hemolytic-Uremic Syndrome

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients With aTypical Hemolytic-Uremic Syndrome (aHUS Registry)

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients who experience specified events [ Time Frame: 10 years ]
    To collect and evaluate safety and effectiveness data specific to the use of eculizumab in aHUS patients.

  • Time to first and subsequent occurrence of specified events. [ Time Frame: 10 years ]
    To assess the long term manifestations of thrombotic microangiopathy (TMA) complications of aHUS as well as other clinical outcomes, including morbidity and mortality in aHUS patients, receiving eculizumab treatment or other disease management approaches


Estimated Enrollment: 2000
Study Start Date: April 2012
Estimated Study Completion Date: December 2025
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Detailed Description:
The study will capture post-marketing safety data on patients treated with eculizumab. Additionally, the study will collect information on the progression of disease in all patients.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female patients of any age, including minors, who have been diagnosed with aHUS; clinical diagnosis of aHUS, patients with or without an identified complement regulatory factor genetic abnormality or anti-complement factor antibody, ADAMTS13 > 5% (if performed)
Criteria

Inclusion Criteria:

  • Male or female patients of any age, including minors, who have been diagnosed with aHUS
  • Able to give written informed consent. Patient or patient's parent/legal guardian must be willing and able to given written informed consent and the patient (if minor) must be willing to give written informed assent [if applicable as determined by the central Institutional Review Boards/Independent Ethics Committees (IRB/IEC)].
  • ADAMTS13 > 5%, if performed.

Exclusion Criteria:

  • Hemolytic Uremic Syndrome (HUS) only due to Shiga Toxin
  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: NCT01522183

Contacts
Contact: Project Manager ahus-registry@incresearch.com

Locations
United States, Ohio
Recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Alexion Pharmaceuticals
INC Research
Investigators
Study Director: Masayo Ogawa, MD, FAACP Alexion Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01522183     History of Changes
Other Study ID Numbers: M11-001
Study First Received: January 18, 2012
Last Updated: February 17, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Alexion Pharmaceuticals:
Atypical Hemolytic-Uremic Syndrome
aHUS
Thrombotic Microangiopathy
TMA

Additional relevant MeSH terms:
Syndrome
Hemolysis
Azotemia
Hemolytic-Uremic Syndrome
Atypical Hemolytic Uremic Syndrome
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 April 24, 2017