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NCT02325674Recruiting

MEASuRE: Metreleptin Effectiveness And Safety Registry

Chiesi Farmaceutici S.p.A.

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

Inclusion Criteria: * Patients treated with metreleptin through commercial supply at the time or before enrolment into registry * Patients who provide a written consent * Patient coming off metreleptin clinical studies and continuing or restarting treatment with metreleptin through commercial supply Exclusion Criteria: • Patients currently treated with an investigational agent as part of a clinical trial

Interventions

DRUG

Metreleptin

Interested in This Trial?

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Conditions

Generalised LipodystrophyPartial Lipodystrophy

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