MEASuRE: Metreleptin Effectiveness And Safety Registry

Partial Lipodystrophy Clinical Trial

— MEASuRE  

Official title:

MEASuRE: Metreleptin Effectiveness And Safety Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02325674
• Other study ID #: AEGR-734-400 / D5560R00003
• Status: Recruiting
• Start date: January 15, 2016
• Est. completion date: October 31, 2031

Study information

• Verified date: November 2022
• Source: Aegerion Pharmaceuticals, Inc.
• Contact: Ruth Louzado
• Phone: +1 855-303-2347
• Email: medinfo[@]amrytpharma.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 31, 2031
• Est. primary completion date: October 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Generalised Lipodystrophy
• Lipodystrophy
• Partial Lipodystrophy

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Leipzig AoeR	Leipzig	Sachsen
Germany	Universitaetsklinikum Muenster	Muenster	Nordrhein Westfalen
Germany	Universitaetsklinikum Ulm	Ulm	Baden Wuerttemberg
Italy	Universita del Piemonte Orientale "Amedeo Avogadro"	Novara	Verceilli
Italy	Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)	Pisa
Italy	Azienda Ospedaliera Universitaria Policlinico Tor Vergata	Roma
United States	University of Michigan	Ann Arbor	Michigan
United States	Atlanta Diabetes Associates	Atlanta	Georgia
United States	Nih/Niddk/Ceb	Bethesda	Maryland
United States	University Alabama at Birmingham	Birmingham	Alabama
United States	Northwestern University Children's Memorial Hospital	Chicago	Illinois
United States	Endocrinology Research Associates	Columbus	Ohio
United States	University Texas Southwestern INT	Dallas	Texas
United States	Detroit Children's Hospital	Detroit	Michigan
United States	City of Hope	Duarte	California
United States	U. of Kansas Hospital	Kansas City	Kansas
United States	Children's Hospital of New Orleans	New Orleans	Louisiana
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Seattle Children's Hospital	Seattle	Washington
United States	Richmond University Medical Centre	Staten Island	New York

Sponsors (1)

Lead Sponsor	Collaborator
Aegerion Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The severity and incidence of the following safety events in patients presribed Metreleptin in routine clinical practice	Estimation of the incidence rates of the following events of special interest in patients treated with metreleptin as part of current clinical practice: acute pancreatitis associated with discontinuation of metreleptin including fatal or necrotizing pancreatitis, hepatic adverse events, severe hypoglycemia, serious hypersensitivity reactions, serious and severe infections resulting in hospitalization or death, loss of efficacy, new diagnoses of autoimmune disorders, autoimmune disease exacerbation, all cancers, exposed pregnancies and pregnancy outcomes, all-cause deaths.	Adverse event will be collected from first dose to last visit - min. 10 years
Secondary	Characteristics of the study population in terms of demographic profile, vital signs and clinical signs	Description of the overall demographic and clinical characteristics in all patients treated with metreleptin (pattern of use analysis)	Demographics and Vital Signs information will be collected at all study visits - min. 10 years
Secondary	Characteristics of the study population in terms of clinical chemistry - Glycated Hemoglobin (HbA1c), Fasting Plasma Glucose (FPG) and Triglycerides (TG)	Description of routine laboratory measurements that could be inferred as efficacy endpoints (including HbA1c, FPG, and TG) over time	Clinical chemistry will be collected at all study visits - min. 10 years
Secondary	Characteristics of the study population in terms of its use of metreleptin	Description of the metreleptin exposure information in all patients treated with metreleptin (pattern of use analysis)	Treatment information will be collected at all study visits - min. 10 years