MEASuRE: SAFETY REGISTRY
Research type
Research Study
Full title
MEASuRE: METRELEPTIN EFFECTIVENESS AND SAFETY REGISTRY
IRAS ID
337473
Contact name
Helen Phillips
Contact email
Sponsor organisation
Amryt Pharmaceuticals DAC
Duration of Study in the UK
7 years, 6 months, 2 days
Research summary
MEASURE is a non-interventional, multicentre, prospective, observational study of patients initiating treatment with metreleptin for lipodystrophy in the US and EEA. It is called Metreleptin Effectiveness and Safety Registry. Lipodystrophy is a rare congenital or acquired syndrome. It is characterized by the generalized or partial absence of adipose tissue, frequently with a muscular appearance. The aim of the study is to collect information about how safe and effective Myalepta® (metreleptin) is in long-term clinical practice. Amryt Pharmaceuticals DAC has been asked to gather this information both by the European Medicine Agency (EMA) and Food and Drug Administration (FDA) in the US.
MEASuRE registry is to add to the knowledge about metreleptin gained from clinical trials and provide the opportunity to obtain further data on the incidence rates of specific safety events and on areas of missing information. Eligible participants are patients who are treated with metreleptin as part of their clinical care. In Europe, the MEASuRE Registry does not have a limit on the number of participants and will remain open indefinitely.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
24/EE/0039
Date of REC Opinion
4 Apr 2024
REC opinion
Further Information Favourable Opinion