MEASuRE: Metreleptin Effectiveness And Safety Registry

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Amryt Pharma
Study ID
NCT02325674
Status
Recruiting
Apply to this trial

Conditions

  • Generalised Lipodystrophy
  • Partial Lipodystrophy

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Metreleptin — DRUG

Study Details

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.

Key Dates

Start date
Oct 11, 2016
Status verified
Jan 2026
Primary completion
Oct 31, 2031
Completion
Oct 31, 2031

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Metreleptin
    Metreleptin new-users Metreleptin prevalent users

Primary Outcome Measure

The severity and incidence of the following safety events in patients prescribed Metreleptin in routine clinical practice [ Time Frame: Adverse events will be collected from first dose to last visit - min. 10 years. For Prevalent Users: Serious adverse events will be collected from 6 months prior to enrolment to last visit - min. 10 years. ]

Central Contacts

Locations (16)

FacilityCityStateZIPSite coordinators
University Alabama at BirminghamBirminghamAlabama40506-
City of HopeDuarteCalifornia91010-
Atlanta Diabetes AssociatesAtlantaGeorgia30318-
Ann & Robert H. Lurie Children's Hospital of ChicagoChicagoIllinois60611
Erika Vucko
Barbara Burton, MD (PRINCIPAL_INVESTIGATOR)
University of Kansas Medical Center Research Institute, Inc.Kansas CityKansas66160
Patrick Moriarty, MD
Patrick Moriarty, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of New Orleans/LSU Health Sciences CenterNew OrleansLouisiana70118-
Ochsner Clinic FoundationNew OrleansLouisiana70121-
Nih/Niddk/DeobBethesdaMaryland20892
Marissa Lightbourne, MD
Marissa Lightbourne, MD (PRINCIPAL_INVESTIGATOR)
University of MichiganAnn ArborMichigan48109
Elif Oral, MD
Elif Oral, MD (PRINCIPAL_INVESTIGATOR)
Childrens Hospital of MichiganDetroitMichigan48201
Vinood Misra
Vinood Misra, MD (PRINCIPAL_INVESTIGATOR)
Richmond University Medical CentreStaten IslandNew York10314-
Endocrinology Research AssociatesColumbusOhio43201
Elena Christofides, MD
Elena Christofides, MD (PRINCIPAL_INVESTIGATOR)
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Shana McCormack, MD
Shana McCormack, MD (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104-
UT Southwestern Medical CenterDallasTexas75390
Abhimanyu Garg, MD
Abhimanyu Garg, MD (PRINCIPAL_INVESTIGATOR)
Seattle Children's HospitalSeattleWashington98105
Helen Dichek, MD
Helen Dichek, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University Alabama at Birmingham· Birmingham, ALCity of Hope· Duarte, CAAtlanta Diabetes Associates· Atlanta, GAAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILUniversity of Kansas Medical Center Research Institute, Inc.· Kansas City, KSChildren's Hospital of New Orleans/LSU Health Sciences Center· New Orleans, LA

Related Studies