Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1 group of subjects receiving 0.057 milligram/kilogram/day (mg/kg/day) or 0.40 mg/kg/week of Saizen® during 1 year to 1 group receiving 0.035 mg/kg/day (0.24 mg/kg/week) of Saizen® during 1 year after an initial 3-year treatment of recombinant human growth hormone (r-hGH) therapy with 0.057 mg/kg/day in both groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Saizen® \[somatropin (recombinant deoxyribonucleic acid \[rDNA\] origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Saizen® \[somatropin (rDNA origin) for injection\], a r-hGH, is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone.
Height Velocity
Height Velocity (HV) is the change in height since the previous year´s measurement and more precisely: HV = {(h-hp)/(d-dp)} \* 365.25 \[centimeter (cm)/year\] where h is current height in cm, hp is previous height in cm, closest to 1 year previous, d is the current date and dp is the date of measurement of previous height, closest to 1 year previous. Additionally, d and dp have to be within 0.6 years and 1.5 years. HV is the mean height velocity over the interval between d and dp but is displayed as HV at d.
Time frame: Month 12
Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12
Height-Standard Deviation Score (H-SDS) was calculated as height minus mean (age-and sex-matched reference) divided by standard deviation (SD) \[age and sex-matched reference\]. Greater H-SDS indicates greater height.
Time frame: Baseline (randomization), Month 6 and Month 12
Height Velocity-Standard Deviation Score (HV-SDS)
Height Velocity-Standard Deviation Score (HV-SDS) was calculated as height velocity minus reference mean height velocity divided by SD of the reference mean height velocity. Greater HV-SDS indicates greater height velocity.
Time frame: Month 6 and Month 12
Change From Baseline in Height at Month 6
Time frame: Baseline (randomization) and Month 6
Change From Baseline in Bone Age at Month 12
Bone age was assessed by a left wrist X-Ray and evaluated by the investigator according to the Greulich and Pyle method.
Time frame: Baseline (randomization) and Month 12
Insulin Like Growth Factor-1 (IGF-1) Levels
Time frame: Baseline (randomization), Month 6 and Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels
Time frame: Baseline (randomization), Month 6 and Month 12
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse Events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs that occur during treatment with the Investigational Medicinal Product (IMP).
Time frame: Baseline (randomization) until Month 12