At a glance
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The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)
In Brief
An observational study evaluating Somatropin (recombinant deoxyribonucleic acid [rDNA] origin) for Growth Hormone (GH) Deficiency and 3 related conditions. Completed, enrolled 22,845 participants.
Detailed Summary
GeNeSIS is an open-label, multinational, multicenter, observational study to evaluate the safety and effectiveness of Humatrope treatment. GeNeSIS is a modular program that includes: * Core study: Evaluating the safety and effectiveness of Humatrope in the observational setting * Genetic Analysis Sub-study: Investigating the genetic defects underlying growth hormone (GH) deficiency and non-GH-deficient growth disorders * Growth Prediction Sub-study: Working to validate and refine specific models to accurately predict growth response to GH * Short Stature Homeobox containing gene (SHOX) Deficiency Sub-study: Elucidating the clinical, endocrine and radiological features of participants with SHOX deficiency due to loss of, or mutation in the SHOX gene (including participants with Turner syndrome) * Neoplasia Sub-study: To characterize the natural history of neoplastic disease, especially in relation to recurrence/progression of primary neoplasia or development of secondary neoplasia in children with a history of neoplasia
Study Details
Timeline
Interventions
Dose, frequency and duration at discretion of attending physician.