Dwarfism, Pituitary Clinical Trial
Official title:
A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen®
This is an open-label, prospective, multicentric, non-comparative, non-randomized Phase IV interventional study in which subjects pre-diagnosed with Growth Hormone Deficiency (GHD) were treated for 4 weeks with Saizen to compare the response between GHD children born appropriate for gestational age (AGA) and those born small for gestation age (SGA) after 4 weeks of Saizen therapy.
The response to growth hormone (GH) treatment, short-term as well as long-term, displays
considerable inter individual variability. This is particularly evident for the endpoint of
paediatric GH administration, that is (i.e.) the growth response, which is pronounced in
children who are affected by GHD. This is an open-label, multicentric study in which
subjects pre-diagnosed with GHD were treated for 4 weeks with Saizen. Two hundred fourteen
GHD evaluable pre-pubertal subjects were planned to be recruited in approximately 9 sites in
China. Demographic data, medical history, tanner stage, physical examination, body weight,
height, bone age measurement, body mass index, review of baseline medications and procedures
and blood sampling were performed at baseline visit, end of treatment visit (week 4) and at
4 week follow-up visit.
OBJECTIVES
Primary objective:
- To compare the response between GHD children born AGA and those born SGA after 4 weeks
of Saizen therapy
Secondary Objectives:
- To explore the contribution of selected genes to the phenotype of GHD children
- To explore the impact of gene polymorphisms on the levels of specific serum biomarkers
in GHD children after 4 weeks of Saizen therapy
- To explore the relationships between changes in gene expression and changes in serum
biomarkers after 4 weeks of Saizen therapy and the spectrum of gene polymorphisms in
GHD children
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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