Clinical Trials in France / NCT02325674
Recruiting
Observational
MEASuRE: Metreleptin Effectiveness And Safety Registry
NCT02325674 · tracked via the Priya Life Science France tracker
Condition(s) studied
Generalised LipodystrophyPartial Lipodystrophy
Investigational drug(s) / intervention(s)
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.
Eligibility
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
Primary outcome measure(s)
- The severity and incidence of the following safety events in patients prescribed Metreleptin in routine clinical practice — 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.
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, medication errors.
Trial sites (28)
| Facility | City | Region | Status |
|---|---|---|---|
| University Alabama at Birmingham | Birmingham | Alabama | Terminated |
| City of Hope | Duarte | California | Terminated |
| Atlanta Diabetes Associates | Atlanta | Georgia | Completed |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | Recruiting |
| University of Kansas Medical Center Research Institute, Inc. | Kansas City | Kansas | Recruiting |
| Children's Hospital of New Orleans/LSU Health Sciences Center | New Orleans | Louisiana | Completed |
| Ochsner Clinic Foundation | New Orleans | Louisiana | Withdrawn |
| Nih/Niddk/Deob | Bethesda | Maryland | Recruiting |
| University of Michigan | Ann Arbor | Michigan | Recruiting |
| Childrens Hospital of Michigan | Detroit | Michigan | Recruiting |
| Richmond University Medical Centre | Staten Island | New York | Completed |
| Endocrinology Research Associates | Columbus | Ohio | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | Recruiting |
| University of Pennsylvania | Philadelphia | Pennsylvania | Withdrawn |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| Seattle Children's Hospital | Seattle | Washington | Recruiting |
| CHRU Hôpital Claude Huriez | Lille | Nord | Recruiting |
| Hôpital Robert Debré | Paris | Paris, France | Recruiting |
| Hôpital Saint-Antoine | Paris | Paris | Recruiting |
| Universitaetsklinikum Ulm | Ulm | Baden-Wurttemberg | Recruiting |
| Kinderkrankenhaus Auf der Bult | Hanover | Lower Saxony | Recruiting |
| Universitaetsklinikum Muenster | Münster | North Rhine-Westphalia | Recruiting |
| Universitaetsklinikum Leipzig AoeR | Leipzig | Saxony | Recruiting |
| Alma Mater Studiorum - Università di Bologna | Bologna | Bologna | Recruiting |
| Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) | Pisa | Pisa | Recruiting |
| Azienda Ospedaliera Universitaria Policlinico Tor Vergata | Roma | Roma | Withdrawn |
| Universita del Piemonte Orientale "Amedeo Avogadro" | Novara | Verceilli | Recruiting |
| Addenbrooke's Hospital | Cambridge | Cambridge | Recruiting |
More Chiesi Farmaceutici S.p.A. trials in France
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02325674 on ClinicalTrials.gov ↗ ← All trials in France