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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 : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Aegerion Pharmaceuticals, Inc.

Brief Summary:
The study is a post-authorization, prospective, voluntary registry of patients treated with metreleptin in the US

Condition or disease
Generalised Lipodystrophy

Detailed Description:

Post Authorisation Safety Registry for US patients with Generalised Lipodystrophy treated with Metreleptin.

This registry will add to the knowledge about metreleptin gained from clinical trials by providing information on the incidence rates of acute pancreatitis, hypoglycemia, hypersensitivity and lymphoma 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
Generalised lipodystrophy patients treated with Metreleptin



Primary Outcome Measures :
  1. Safety of multiple doses of Metreleptin in terms of adverse events incidence [ Time Frame: Adverse event will be collected from first dose to last visit - up to 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: fatal or necrotizing pancreatitis, hepatic adverse events, severe hypoglycemia, serious hypersensitivity reactions, serious infections resulting in hospitalization or death, 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 - up to 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 - up to 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 - up to 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 with Generalised Lipodystrophy treated with Metreleptin
Criteria

Inclusion Criteria:

  • Patients who are treated with metreleptin as part of clinical care
  • Patients who provide a written consent

Exclusion Criteria:

  • Patient receiving metreleptin as part of a clinical trial or through expanded access including compassionate use
  • 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: Melanie Olesky +1 855-303-2347 medinfo@amrytpharma.com

Locations
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United States, Alabama
University Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 40506
Contact: Ambika Ashraf    205-638-9107    aashraf@peds.uab.edu   
Principal Investigator: Ambika Ashraf, MD         
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Behrouz Salehian, MD    626-256-2251    bsalehian@coh.org   
Principal Investigator: Behrouz Salehian, MD         
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Contact: Jonathan Ownby, MD    404-355-4393    jownby@atlantadiabetes.com   
Principal Investigator: Jonathan Ownby, MD         
United States, Illinois
Northwestern University Children's Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
Contact: Barbara Burton, MD    773-880-3058    bburton@luriechildrens.org   
Principal Investigator: Barbara Burton, MD         
United States, Kansas
U. of Kansas Hospital Recruiting
Kansas City, Kansas, United States, 66160
Contact: Patrick Moriarty, MD    913-588-4064    pmoriart@kumc.edu   
Principal Investigator: Patrick Moriarty, MD         
United States, Louisiana
Children's Hospital of New Orleans Recruiting
New Orleans, Louisiana, United States, 70118
Contact: Dania Felipe-Ramirez, MD    504-896-9441    dfelip@lsuhsc.edu   
Principal Investigator: Dania Felipe-Ramirez, MD         
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Gabriel Uwaifo    504-842-1264    gabriel.uwaifo@ochsner.org   
Principal Investigator: Gabriel Uwaifo, MD         
United States, Maryland
Nih/Niddk/Ceb Recruiting
Bethesda, Maryland, United States, 20892
Contact: Elaine Cochran, NP    301-496-2718    elaine_cochran@nih.gov   
Principal Investigator: Elaine Cochran, NP         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Elif Oral, MD    734-615-7271    eliforal@med.umich.edu   
Principal Investigator: Elif Oral, MD         
United States, New York
Richmond University Medical Centre Recruiting
Staten Island, New York, United States, 10314
Principal Investigator: Svetlana Ten, MD         
United States, Ohio
Endocrinology Research Associates Recruiting
Columbus, Ohio, United States, 43201
Contact: Elena Christofides, MD    614-824-5865    christofides@endocrinology-associates.com   
Principal Investigator: Elena Christofides, MD         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Shana McCormack, MD    215-590-1000    mccormacks1@email.chop.edu   
Principal Investigator: Shana McCormack, MD         
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Daniel Radar, MD    215-615-0800    rader@mail.med.upenn.edu   
Principal Investigator: Daniel Radar         
United States, Texas
University Texas Southwestern INT Recruiting
Dallas, Texas, United States, 75390
Contact: Abhimanyu Garg, MD    214-648-2895    abhimanyu.garg@utsouthwestern.edu   
Principal Investigator: Abhimanyu Garg, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Helen Dichek, MD    206-987-4056    helen.dichek@seattlechildrens.org   
Principal Investigator: Helen Dichek, MD         
Sponsors and Collaborators
Aegerion Pharmaceuticals, Inc.
Investigators
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Study Director: Melanie Olesky 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: January 26, 2021
Last Verified: January 2021
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