Predictive Markers in Chinese Growth Hormone Deficiency (GHD) Children Treated With Saizen®
|Dwarfism, Pituitary||Drug: Recombinant human growth hormone (r-hGH)||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase IV Open-label Study of Predictive Markers in Growth Hormone Deficient Pre-pubertal Children Treated With Saizen®|
- Change From Baseline in Serum Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) Levels at Week 4 [ Time Frame: Baseline and Week 4 ]Insulin Like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was calculated as logarithm (log) 10 actual value of IGF-1 - log 10 (mean reference value of IGF-1) divided by log10 reference standard deviation of IGF-1.
- Change From Baseline in Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels at Week 4 [ Time Frame: Baseline and Week 4 ]
- Change From Baseline in Fasting Glucose at Week 4 [ Time Frame: Baseline and Week 4 ]
- Change From Baseline in Fasting Insulin at Week 4 [ Time Frame: Baseline and Week 4 ]
- Change From Baseline in Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) Test at Week 4 [ Time Frame: Baseline and Week 4 ]HOMA-IR is used to assess insulin resistance and calculated by an empirical mathematical formula based on fasting plasma glucose and fasting plasma insulin levels. HOMA-IR = fasting plasma insulin (picomole/liter [pmol/L]) * fasting plasma glucose (millimole/liter [mmol/L]) divided by 22.5.
- Change From Baseline in Lipid Profile at Week 4 [ Time Frame: Baseline and Week 4 ]Total cholesterol, high-density lipoprotein (HDL)-cholesterol, low-density lipoprotein (LDL)-cholesterol and triglycerides levels were evaluated.
|Study Start Date:||March 2007|
|Estimated Study Completion Date:||April 2009|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Drug: Recombinant human growth hormone (r-hGH)
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.
- To compare the response between GHD children born AGA and those born SGA after 4 weeks of Saizen therapy
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187550
|Study Director:||Medical Responsible||Merck Serono Co., Ltd., China|