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MEASuRE: Metreleptin Effectiveness And Safety Registry (MEASuRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02325674
Recruitment Status : Recruiting
First Posted : December 25, 2014
Last Update Posted : November 29, 2022
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Brief 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.

Condition or disease
Generalised Lipodystrophy Partial Lipodystrophy

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Metreleptin

Group/Cohort
Metreleptin

Metreleptin new-users

Metreleptin prevalent users




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in the US with Generalised Lipodystrophy treated with commercial Metreleptin, and patients in the EEA with either Generalise Lipodystrophy or Partial Lipodystrophy, treated with commercial Metreleptin
Criteria

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


Information from the National Library of Medicine

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


Contacts
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Contact: Ruth Louzado +1 855-303-2347 medinfo@amrytpharma.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Aegerion Pharmaceuticals, Inc.
Investigators
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Study Director: Ruth Louzado Amryt Pharma
Additional Information:

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Responsible Party: Aegerion Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT02325674    
Other Study ID Numbers: AEGR-734-400 / D5560R00003
First Posted: December 25, 2014    Key Record Dates
Last Update Posted: November 29, 2022
Last Verified: November 2022
Keywords provided by Aegerion Pharmaceuticals, Inc.:
Lipodystrophy
Metreleptin Registry
Additional relevant MeSH terms:
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Lipodystrophy
Skin Diseases, Metabolic
Skin Diseases
Lipid Metabolism Disorders
Metabolic Diseases