Global Patient Registry to Track Long-Term Safety and Effectiveness of Increlex4 in Children and Teens with Severe Primary IGF-1 Deficiency

What this Trial Is About

Researchers are conducting a global registry to monitor the long-term safety and effectiveness of Increlex therapy in children and adolescents with Severe Primary Insulin-like Growth Factor-1 Deficiency SPIGFD. This observational, non-interventional registry collects data from multiple countries including Austria, France, Germany, Italy, Poland, Spain, Sweden, the United Kingdom, and the USA. The main goal is to gather safety information during treatment and for at least five years after treatment ends. The registry includes participants who are starting, planning to start, or already receiving Increlex treatment as per local prescribing information. Increlex mecasermin is given as an injection with doses ranging from 40 to 120 mcgkg twice daily, prescribed by a physician. Data may be collected retrospectively for those already on treatment. The study tracks participants over long periods to observe treatment exposure, dose, and various health outcomes related to growth and development. Participants will be monitored for adverse events, including serious events and neoplasia, during treatment and up to five years afterward. Researchers will also assess changes in height, bone age, body mass index, pubertal stage, and quality of life. Biological markers like growth hormone and IGF-1 levels will be measured periodically. The registry collects comprehensive data on safety, effectiveness, and other health indicators to better understand outcomes in children and adolescents receiving Increlex therapy.

Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).