aHUS Observational Long Term Follow-Up (LTFU)

February 22, 2017 updated by: Alexion Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • North Tce. Adelaide, Australia
        • Royal Adelaide Hospital
  • Austria
      • Graz, Austria
        • Universitatsklinik fur Innere Medizin Medizinische Universitat Graz
      • Innsbruck, Austria
        • Medizinische Universitaet Innsbruck
  • Belgium
      • Gent, Belgium
        • UZ Gent Dienst nefrologie
      • Liège, Belgium
        • CHU Sart Tilman
  • Canada
      • Montreal, Canada
        • Centre Hospitalier Universitaire (CHU) Sainte-Justine
      • Toronto, Canada
        • The Hospital for Sick Children
  • France
      • Bordeaux Cedex, France
        • Centre Hospitalier Universitaire Pellegrin, Service de Nephrologie Transplantation Dialyse
      • Caen, France
        • CHRU de Caen
      • Le Kremlin Bicetre, France
        • Le Kremlin Bicetre Hospital, Nephrology Unit
      • Lille, France
        • CHRU de Lille-Hopital A.Calmette
      • Lyon, France
        • Hôpital Edouard Herriot
      • Marseille, France
        • Hopital de la Timone Enfants, Unité de Néphrologie
      • Nantes, France
        • CHU Hôtel Dieu
      • Nice, France
        • Le Centre Hospitalier Universitaire de Nice
      • Orleans, France
        • Centre Hospitalier Regional de la Source, Service de nephrologie/hemodialyse
      • Paris, France
        • Hôpital Tenon
      • Paris, France
        • Hopital Robert-Debré, Service de Néphrologie Pédiatrique
      • Quimper, France
        • Centre Hospitalier Inter-Communal de Cornouaille
      • Rouen, France
        • CHU-CH Charles Nicolle Pavillon de Pédiatrie
      • Rouen Cedex, France
        • Hôpital de Bois Guillaume CHU de Rouen
      • Saint Priest En Jarez, France
        • CHU de Saint-Etienne
      • Strasbourg, France
        • Nouvel Hôpital Civil
      • Tours, France
        • CHRU de Tours
  • Germany
      • Aachen, Germany
        • Universitaetsklinikum Aachen Klinik fuer Nieren- und Hochdruckkrankheiten
      • Hannover, Germany
        • Hannover University Clinic
      • Heidelberg, Germany
        • Universitaet Heidelberg
  • Italy
      • Bergamo, Italy
        • A.O. Papa Giovanni XXIII
      • Firenze, Italy
        • Azienda Ospedaliero-Universitaria Careggi
      • Genova, Italy
        • Istituto Giannina Gaslini
      • Milano, Italy
        • Fondazione IRCCS Ca Granda, Ospedale Maggiore Policlinico Maggiore Policlinico
      • Palermo, Italy
        • Ospedale dei Bambini G. Di Cristina
  • Netherlands
      • Amsterdam, Netherlands
        • AMC Medical Research B.V.
      • Nijmegen, Netherlands
        • Radboud University Nijmegen Medical Centre Nijmegen
  • Sweden
      • Stockholm, Sweden
        • Nephrology Clinic, Karolinska University Hospital
  • Switzerland
      • Bern, Switzerland
        • INSELSPITAL Universitaetsklinik fuer Kinderheilkunde Kindernephrologie
  • United Kingdom
      • Exeter, United Kingdom
        • Royal Devon & Exeter NHS Foundation Trust
      • Glasgow, United Kingdom
        • Gartnavel General Hospital
      • Newcastle upon Tyne, United Kingdom
        • The Newcastle upon Tyne Hospitals NHS
      • Nottingham, United Kingdom
        • City Hospital, Nottingham University Hospitals, NHS Trust
  • United States
    • Georgia
      • Atlanta, Georgia, United States
        • Emory Healthcare - Children's Center
      • Dunwoody, Georgia, United States
        • Dunwoody Pediatrics & Children's Healthcare of Atlanta
    • Indiana
      • Fort Wayne, Indiana, United States
      • Fort Wayne, Indiana, United States
        • Fort Wayne Medical Oncology and Hematology
    • Massachusetts
      • Boston, Massachusetts, United States
        • Boston Children's Hospital
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Health System
    • New York
      • Bronx, New York, United States
        • Children's Hospital at Montefiore
      • Hawthorne, New York, United States
        • Hudson Valley Oncology Hematology
      • New York, New York, United States
        • Weill Cornell Medical College
    • Ohio
      • Cincinnati, Ohio, United States
        • Cincinnati Children's Hospital
      • Columbus, Ohio, United States
        • Arthur James Cancer Hospital
    • Texas
      • Corpus Christi, Texas, United States
        • Driscoll Children's Hospital
      • Houston, Texas, United States
        • The Methodist Hospital Research Institute
    • Washington
      • Seattle, Washington, United States
        • Seattle Children's Hospital
      • Spokane, Washington, United States
        • Providence Sacred Heart Medical Center & Children's Hospital
    • Wisconsin
      • Osh Kosh, Wisconsin, United States
        • Fox Valley Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female aHUS, including minors, who previously participated in eculizumab clinical trials.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 Years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2012

Primary Completion (ACTUAL)

January 1, 2017

Study Completion (ACTUAL)

January 1, 2017

Study Registration Dates

First Submitted

January 18, 2012

First Submitted That Met QC Criteria

January 27, 2012

First Posted (ESTIMATE)

January 31, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C11-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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