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aHUS Observational Long Term Follow-Up (LTFU)

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ClinicalTrials.gov Identifier: NCT01522170
Recruitment Status : Terminated (Remaining patients were offered a similar observational study (Alexion M11-001) to allow for robust, high quality data collection in a larger, single database)
First Posted : January 31, 2012
Last Update Posted : February 24, 2017
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Brief Summary:
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 or disease
Atypical Hemolytic Uremic Syndrome

Study Type : Observational [Patient Registry]
Actual Enrollment : 94 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 5 Years
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
Actual Study Start Date : March 2012
Actual Primary Completion Date : January 2017
Actual Study Completion Date : January 2017





Primary Outcome Measures :
  1. TMA complication-free survival [ Time Frame: 5 Years ]
    Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.


Secondary Outcome Measures :
  1. Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention [ Time Frame: 5 Years ]
    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.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01522170


  Show 56 Study Locations
Sponsors and Collaborators
Alexion Pharmaceuticals

Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01522170     History of Changes
Other Study ID Numbers: C11-003
First Posted: January 31, 2012    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017

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

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