Turner Syndrome Clinical Trial
Official title:
First Year Growth Response Associated Genetic Markers Validation Phase IV Open-label Study in Growth Hormone Deficient and Turner Syndrome Pre-pubertal Children: the PREDICT Pharmacogenetics Validation Study
PREDICT Validation is a validation pharmacogenetic trial. The purpose of this study is to confirm that some genes can be used to predict how well a subject diagnosed with idiopathic growth hormone deficiency (IGHD) or turner syndrome (TS) will respond to a treatment with recombinant human growth hormone (r-hGH).
This study is an open-label, interventional, retrospective, multicenter, international
study, single-arm, non-randomized, and non-controlled study. The subject's trial
participation includes a single visit. During the visit, subjects who give consent to
participate in the trial will undergo blood sampling for genetic markers testing and
retrospective data will be collected relative to the first year of the subject's r-hGH
treatment.
The r-hGH treatment followed by the subject is indicated the pediatric population, therefore
most of the subjects included into the trial will be below 18 years old.
This study is a non-investigational medicinal product (IMP) trial therefore no drug product
data is provided.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
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