Clincosm LogoSign in Get a demo

MEASuRE: Metreleptin Effectiveness And Safety Registry

Sponsor
Aegerion Pharmaceuticals, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02325674
Collaborator
(none)
100
Enrollment
15
Locations
189.5
Duration (Months)
6.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    MEASuRE: Metreleptin Effectiveness And Safety Registry
    Study Start Date :
    Jan 15, 2016
    Anticipated Primary Completion Date :
    Oct 31, 2031
    Anticipated Study Completion Date :
    Oct 31, 2031

    Arms and Interventions

    Arm Intervention/Treatment
    Metreleptin

    Generalised lipodystrophy patients treated with Metreleptin

    Outcome Measures

    Primary Outcome Measures

    1. Safety of multiple doses of Metreleptin in terms of adverse events incidence [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 [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) [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 [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Alabama at Birmingham Birmingham Alabama United States 40506
    2 City of Hope Duarte California United States 91010
    3 Atlanta Diabetes Associates Atlanta Georgia United States 30318
    4 Northwestern University Children's Memorial Hospital Chicago Illinois United States 60611
    5 U. of Kansas Hospital Kansas City Kansas United States 66160
    6 Children's Hospital of New Orleans New Orleans Louisiana United States 70118
    7 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
    8 Nih/Niddk/Ceb Bethesda Maryland United States 20892
    9 University of Michigan Ann Arbor Michigan United States 48105
    10 Richmond University Medical Centre Staten Island New York United States 10314
    11 Endocrinology Research Associates Columbus Ohio United States 43201
    12 Children's Hospital of Philadelphia Philadelphia Pennsylvania United States 19104
    13 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    14 University Texas Southwestern INT Dallas Texas United States 75390
    15 Seattle Children's Hospital Seattle Washington United States 98105

    Sponsors and Collaborators

    • Aegerion Pharmaceuticals, Inc.

    Investigators

    • Study Director: Melanie Olesky, Amryt Pharma

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aegerion Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT02325674
    Other Study ID Numbers:
    • AEGR-734-400 / D5560R00003
    First Posted:
    Dec 25, 2014
    Last Update Posted:
    Jan 26, 2021
    Last Verified:
    Jan 1, 2021
    Keywords provided by Aegerion Pharmaceuticals, Inc.
    Lipodystrophy
    Metreleptin Registry
    Additional relevant MeSH terms:
    Lipodystrophy

    Study Results

    No Results Posted as of Jan 26, 2021