aHUS Observational Long Term Follow-Up (LTFU)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01522170
First received: January 18, 2012
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.


Condition
Atypical Hemolytic Uremic Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical Study

Resource links provided by NLM:


Further study details as provided by Alexion Pharmaceuticals:

Primary Outcome Measures:
  • TMA complication-free survival [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.


Secondary Outcome Measures:
  • Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention [ Time Frame: 5 Years ] [ Designated as safety issue: No ]
    Assess the long term safety of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study by collecting data on serious adverse events and targeted adverse events.


Estimated Enrollment: 150
Study Start Date: March 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: December 2017 (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 and female aHUS, including minors, who previously participated in eculizumab clinical trials.

Criteria

Inclusion Criteria:

  • aHUS patients who participated in any one of the aHUS-eculizumab clinical studies.
  • aHUS patients or legal representative who are able and willing to given written informed consent for their study information to be collected and retained in a database.

Exclusion Criteria:

  • Not applicable.
  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: NCT01522170

Locations
United States, Indiana
Fort Wayne, Indiana, United States
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

No publications provided

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01522170     History of Changes
Other Study ID Numbers: C11-003
Study First Received: January 18, 2012
Last Updated: July 9, 2013
Health Authority: United States: Institutional Review Board
European Union: European Medicines Agency

Keywords provided by Alexion Pharmaceuticals:
Atypical Hemolytic Uremic Syndrome
aHUS
Eculizumab

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

ClinicalTrials.gov processed this record on October 29, 2014