Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age

Optimization of the Dosage Regimen With Growth Hormone Therapy in Children Born Small for Gestational Age. An Open Label, Randomized, Pilot Study, Comparing in Children Treated for 3 Years, the Efficacy of a Saizen® Treatment at the Same Dose Versus a Lower Maintenance Dose Prolonged During 1 Additional Year.

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.

Inclusion Criteria:

To be eligible for inclusion / randomization into this study, the subjects must fulfill all of the following criteria (if there is no inclusion phase, the inclusion criteria will be considered as inclusion criteria for randomization):

• Written consent form signed by the parents / legal guardian, and child if possible
• Subject born SGA and receiving a r-hGH therapy for this pathology
• Recombinant human growth hormone (r-hGH) started at the maximal chronological age of 7 years for girls and 8 years for boys
• Treatment with r-hGH started for at least 30 months and less than 36 months at 0.057 mg/kg/day
• Height gain during the first 2 years of GH treatment > 1 SD compared with the initial value

Exclusion Criteria:

To be eligible for inclusion in this study the subjects must not meet any of the following criteria:

• Known hypersensitivity to Somatropin or any of the excipients
• Active neoplasia (either newly diagnosed or recurrent)
• Intracranial hypertension
• Known diabetes mellitus
• Proliferative or preproliferative diabetic retinopathy
• Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
• Obesity defined as degree 1 on the corpulence curves
• Precocious puberty
• Pubertal status: Tanner breast development stage > 2 for girls, and testicular volume > 4 milliliter (mL) or testicular length > 3 centimeter (cm) and/or testosterone value >1 nanomole/liter [nmol/L] (0.29 gram/mL [g/mL]) for boys For girls > 9 years and Tanner breast development stage 1: uterine size > 35 millimeter (mm)
• Severe chronic concomitant illness such as chronic renal failure, cystic fibrosis
• Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
• Participation to any clinical study within the 30 days preceding study entry