Growth Hormone (GH) Deficiency Clinical Trial
Official title:
The Genetics and Neuroendocrinology of Short Stature International Study (GeNeSIS)
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
n/a