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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02325674
Study type Observational [Patient Registry]
Source Aegerion Pharmaceuticals, Inc.
Contact Ruth Louzado
Phone +1 855-303-2347
Email medinfo@amrytpharma.com
Status Recruiting
Phase
Start date January 15, 2016
Completion date October 31, 2031

See also
  Status Clinical Trial Phase
Recruiting NCT05470504 - Study of Growth Hormone Inhibition Using Pegvisomant in Severe Insulin Resistance Phase 2
Recruiting NCT05164341 - Study to Evaluate the Safety and Efficacy of Daily Subcutaneous Metreleptin Treatment in Subjects With PL Phase 3
Completed NCT00896298 - Trial of Leptin Replacement Therapy in Patients With Lipodystrophy Phase 2/Phase 3