MEASuRE: Metreleptin Effectiveness And Safety Registry
Start Date
10/11/2016
Completion Date
10/31/2031
Summary
The study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the US and EEA.
Detailed Description
This is a non-interventional, multicentre, prospective, observational study of patients receiving treatment with commercial metreleptin for lipodystrophy in the US (GL) and EEA (GL and PL). This registry will add to the knowledge about metreleptin gained from clinical trials by providing information on the incidence rates of acute pancreatitis associated with the discontinuation of metreleptin; and all cases of fatal or necrotizing pancreatitis, hepatic adverse events, hypoglycemia, hypersensitivity reactions, serious and severe infections, including serious infections resulting in hospitalization and death, loss of efficacy, new diagnoses of autoimmune disorders, exacerbation of existing autoimmune disorders, all cancers (excluding non-melanoma skin cancer) by cancer type, exposed pregnancies, and all-cause deaths, in patients treated with metreleptin in routine clinical practice.
Eligibility Criteria
Age Range: No minimum to No maximum
Interventions
Metreleptin
Conditions
Locations
University Alabama at Birmingham
Birmingham, Alabama 40506
United States
City of Hope
Duarte, California 91010
United States
Atlanta Diabetes Associates
Atlanta, Georgia 30318
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
United States
University of Kansas Medical Center Research Institute, Inc.
Kansas City, Kansas 66160
United States
Children's Hospital of New Orleans/LSU Health Sciences Center
New Orleans, Louisiana 70118
United States
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
United States
Nih/Niddk/Deob
Bethesda, Maryland 20892
United States
University of Michigan
Ann Arbor, Michigan 48109
United States
Childrens Hospital of Michigan
Detroit, Michigan 48201
United States
Richmond University Medical Centre
Staten Island, New York 10314
United States
Endocrinology Research Associates
Columbus, Ohio 43201
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States
UT Southwestern Medical Center
Dallas, Texas 75390
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
CHRU Hôpital Claude Huriez
Lille, Nord 59800
France
Hôpital Robert Debré
Paris, Paris, France 75019
France
Hôpital Saint-Antoine
Paris, Paris 75012
France
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg 89075
Germany
Kinderkrankenhaus Auf der Bult
Hanover, Lower Saxony 0000
Germany
Universitaetsklinikum Muenster
Münster, North Rhine-Westphalia 48149
Germany
Universitaetsklinikum Leipzig AoeR
Leipzig, Saxony 04103
Germany
Alma Mater Studiorum - Università di Bologna
Bologna, Bologna 40126
Italy
Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)
Pisa, Pisa 56124
Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, Roma 00133
Italy
Universita del Piemonte Orientale "Amedeo Avogadro"
Novara, Verceilli 13100
Italy
Addenbrooke's Hospital
Cambridge, Cambridge CB2 0QQ
United Kingdom