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NCT02325674 · ClinicalTrials.gov registry record
MEASuRE: Metreleptin Effectiveness And Safety Registry
A clinical trial of Partial Lipodystrophy and Generalised Lipodystrophy, sponsored by Amryt Pharma.
- Recruiting
- Registry status
- 100
- Enrollment target
- 20
- Study locations
NCT02325674: Recruiting study of Partial Lipodystrophy and Generalised Lipodystrophy, sponsored by Amryt Pharma.
NCT02325674 is a study of Partial Lipodystrophy and Generalised Lipodystrophy that is actively recruiting participants, run by Amryt Pharma. The registered enrollment target is 100 participants. The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02325674, a study of Partial Lipodystrophy and Generalised Lipodystrophy, is actively recruiting participants, sponsored by Amryt Pharma.
- RECRUITING
- Registry status
- 100 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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 exacerbati
Conditions Studied
Interventions
- DRUG Metreleptin
Study Locations (20)
Louisiana
- Children's Hospital of New Orleans/LSU Health Sciences Center - New Orleans
- Ochsner Clinic Foundation - New Orleans
Michigan
- University of Michigan - Ann Arbor
- Childrens Hospital of Michigan - Detroit
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
- University of Pennsylvania - Philadelphia
Alabama
- University Alabama at Birmingham - Birmingham
California
- City of Hope - Duarte
Georgia
- Atlanta Diabetes Associates - Atlanta
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Kansas
- University of Kansas Medical Center Research Institute, Inc. - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2016-10-11 |
| Est. Completion | 2031-10-31 |
What NCT02325674 shows while recruiting
NCT02325674 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with Partial Lipodystrophy appearing as the primary indexed condition, and to 1 intervention - of which Metreleptin is the first listed.
NCT02325674 names 20 study sites across 17 states, led by Louisiana, Michigan, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02325674 about?
NCT02325674 is a clinical study titled "MEASuRE: Metreleptin Effectiveness And Safety Registry". 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.
What is the current status of trial NCT02325674?
This trial is currently recruiting. The enrollment target is 100 participants. The study started on 2016-10-11. Estimated completion is 2031-10-31.
What conditions does trial NCT02325674 study?
This clinical trial studies the following conditions: Partial Lipodystrophy, Generalised Lipodystrophy.
What interventions are being tested in trial NCT02325674?
The interventions under investigation include: Metreleptin (DRUG).
Who is sponsoring clinical trial NCT02325674?
This trial is sponsored by Amryt Pharma, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02325674 being conducted?
This trial has 20 study locations across Alabama, California, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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