Registry for patients treated with metreleptin for lipodystrophy
MEASuRE: Metreleptin Effectiveness And Safety Registry
Amryt Pharma · NCT02325674
This study is collecting information from patients with lipodystrophy who are being treated with metreleptin to see how well it works and what side effects it might cause in real life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Amryt Pharma (industry) |
| Locations | 28 sites (Birmingham, Alabama and 27 other locations) |
| Trial ID | NCT02325674 on ClinicalTrials.gov |
What this trial studies
This is a prospective, observational registry that collects data on patients receiving metreleptin treatment for generalized and partial lipodystrophy. The study aims to gather real-world evidence on the safety and effectiveness of metreleptin, focusing on various adverse events and treatment outcomes. Patients enrolled in the registry will be monitored for complications such as pancreatitis, hepatic events, and autoimmune disorders, contributing to a better understanding of metreleptin's impact in routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this registry are patients currently receiving metreleptin treatment or those transitioning from clinical trials to commercial treatment.
Not a fit: Patients currently participating in investigational clinical trials with other agents will not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the long-term safety and effectiveness of metreleptin, improving treatment strategies for patients with lipodystrophy.
How similar studies have performed: Other observational studies have successfully provided insights into treatment outcomes for similar conditions, suggesting that this approach could yield meaningful data.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Birmingham, Alabama and 27 other locations
- University Alabama at Birmingham — Birmingham, Alabama, United States (TERMINATED)
- City of Hope — Duarte, California, United States (TERMINATED)
- Atlanta Diabetes Associates — Atlanta, Georgia, United States (ACTIVE_NOT_RECRUITING)
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (RECRUITING)
- University of Kansas Medical Center Research Institute, Inc. — Kansas City, Kansas, United States (RECRUITING)
- Children's Hospital of New Orleans/LSU Health Sciences Center — New Orleans, Louisiana, United States (COMPLETED)
- Ochsner Clinic Foundation — New Orleans, Louisiana, United States (WITHDRAWN)
- Nih/Niddk/Deob — Bethesda, Maryland, United States (RECRUITING)
- University of Michigan — Ann Arbor, Michigan, United States (RECRUITING)
- Childrens Hospital of Michigan — Detroit, Michigan, United States (RECRUITING)
- Richmond University Medical Centre — Staten Island, New York, United States (COMPLETED)
- Endocrinology Research Associates — Columbus, Ohio, United States (RECRUITING)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (RECRUITING)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (WITHDRAWN)
- UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
- Seattle Children's Hospital — Seattle, Washington, United States (RECRUITING)
- CHRU Hôpital Claude Huriez — Lille, Nord, France (RECRUITING)
- Hôpital Robert Debré — Paris, Paris, France, France (RECRUITING)
- Hôpital Saint-Antoine — Paris, France (RECRUITING)
- Universitaetsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany (RECRUITING)
- Kinderkrankenhaus Auf der Bult — Hanover, Lower Saxony, Germany (RECRUITING)
- Universitaetsklinikum Muenster — Münster, North Rhine-Westphalia, Germany (RECRUITING)
- Universitaetsklinikum Leipzig AoeR — Leipzig, Saxony, Germany (RECRUITING)
- Universita del Piemonte Orientale "Amedeo Avogadro" — Novara, Verceilli, Italy (RECRUITING)
- Alma Mater Studiorum - Università di Bologna — Bologna, Italy (RECRUITING)
- Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello) — Pisa, Italy (RECRUITING)
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Roma, Italy (WITHDRAWN)
- Addenbrooke's Hospital — Cambridge, United Kingdom (RECRUITING)
Study contacts
- Study coordinator: Lori Hartnett
- Email: clinicaltrials_info@chiesi.com
- Phone: +3905212791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Generalised Lipodystrophy, Partial Lipodystrophy, Lipodystrophy, Metreleptin Registry