MEASuRE: Metreleptin Effectiveness And Safety Registry

Aegerion Pharmaceuticals

Status

Enrolling

Conditions

Generalised Lipodystrophy

Partial Lipodystrophy

Treatments

Drug: Metreleptin

Study type

Observational

Funder types

Industry

Identifiers

NCT02325674

AEGR-734-400 / D5560R00003

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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