MEASuRE: Metreleptin Effectiveness And Safety Registry (MEASuRE)
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|ClinicalTrials.gov Identifier: NCT02325674|
Recruitment Status : Recruiting
First Posted : December 25, 2014
Last Update Posted : November 29, 2022
|Condition or disease|
|Generalised Lipodystrophy Partial Lipodystrophy|
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 Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||MEASuRE: Metreleptin Effectiveness And Safety Registry|
|Study Start Date :||January 15, 2016|
|Estimated Primary Completion Date :||October 31, 2031|
|Estimated Study Completion Date :||October 31, 2031|
Metreleptin prevalent users
- The severity and incidence of the following safety events in patients presribed Metreleptin in routine clinical practice [ Time Frame: Adverse event will be collected from first dose to last visit - min. 10 years ]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.
- Characteristics of the study population in terms of demographic profile, vital signs and clinical signs [ Time Frame: Demographics and Vital Signs information will be collected at all study visits - min. 10 years ]Description of the overall demographic and clinical characteristics in all patients treated with metreleptin (pattern of use analysis)
- Characteristics of the study population in terms of clinical chemistry - Glycated Hemoglobin (HbA1c), Fasting Plasma Glucose (FPG) and Triglycerides (TG) [ Time Frame: Clinical chemistry will be collected at all study visits - min. 10 years ]Description of routine laboratory measurements that could be inferred as efficacy endpoints (including HbA1c, FPG, and TG) over time
- Characteristics of the study population in terms of its use of metreleptin [ Time Frame: Treatment information will be collected at all study visits - min. 10 years ]Description of the metreleptin exposure information in all patients treated with metreleptin (pattern of use analysis)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02325674
|Contact: Ruth Louzado||+1 firstname.lastname@example.org|
|Study Director:||Ruth Louzado||Amryt Pharma|