Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Condition: Small Gestational Age (SGA)
Intervention: Saizen®; Saizen®
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 6 Years
Maximum age: 11 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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