Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated at Least 3 Years or Until Near Final Height, When Applicable, in Comparison With a Historic Cohort of Non-treated Children
Efficacy and Safety Evaluation of Recombinant Human Growth Hormone (r-hGH), Saizen®, on a Population of Children With Hypochondroplasia, Treated at Least 3 Years or Until Near Final Height, When Applicable, in Comparison With a Historic Cohort of Non-treated Children
This study is conducted to describe the efficacy and safety of recombinant human growth
 hormone (r-hGH) treatment Saizen® on children with hypochondroplasia.
Inclusion Criteria:

 -  Male or female children with hypochondroplasia defined by a disproportional short limb
 height and a X-ray evidence of shortening of the long bones and failure of increase in
 the interpedicular distance between lumbar vertebrae L1 and L5

 -  Result of genetic analysis for mutation of gene FGFR3 already known or ongoing
 analysis at the beginning of the study

 -  Chronological age greater than or equal to 3 years

 -  Height for chronological age less than or equal to - 2 SDS

 -  Bone age less than or equal to 11 years for girls and 13 years for boys

 -  A written informed consent at the beginning of the pre-treatment period must be
 obtained from the parent(s)/legal guardian(s). Children able to understand the trial
 should personally sign and date the written informed consent

 Additional inclusion criteria for each study prolongation:

 -  Bone age at Month 36 or Month 60 is compatible with treatment prolongation according
 to investigator opinion

 -  Subject is still under r-hGH treatment with Saizen® at Month 36 or Month 60

 -  Height gain greater than or equal to + 1 SDS after the 2 first years of treatment for
 treatment prolongation at Month 36 and growth velocity greater than or equal to 5
 centimeter (cm) per year, with bone age less than 14 years for females or less than 16
 years for males for treatment prolongation at Month 60

 -  According to investigator opinion, gene mutations of the subjects are not in
 connection with observed side effects during the 3 or 5 first years of treatment

 -  An updated written informed consent must be obtained from the parent(s)/legal
 guardian(s) before the start of each study prolongation. Children able to understand
 the trial should personally sign and date the written informed consent

 Exclusion Criteria:

 -  Turner's Syndrome in girls

 -  Active malignant neoplastic disease

 -  Severe congenital malformations

 -  Proliferative or preproliferative diabetic retinopathy

 -  Evidence of any progression or recurrence of an underlying intra-cranial space
 occupying lesion

 -  Severe psychomotor retardation

 -  Diabetes mellitus or history of significant glucose intolerance as defined by a
 fasting blood glucose greater than 6.4 millimole per liter (mmol/L)

 -  Known renal insufficiency as defined by serum creatinine level 1.0 milligram per
 deciliter (mg/dL) (88 micromole per liter [mcmol/L])

 -  Known hepatic disease as defined by elevated liver enzymes or total bilirubin (* 2
 Normal)

 -  Current congestive heart failure, untreated hypertension, serious chronic edema of any
 cause

 -  Chronic infectious disease

 -  History of intracranial hypertension with papilledema

 -  Previous or ongoing treatment with sex steroid therapy such as estrogens or
 testosterone

 -  Previous or ongoing treatment with any therapy that may directly influence growth,
 including Growth Hormone (GH), Growth Hormone Releasing Hormone (GHRH) and long
 duration corticosteroids therapy

 -  Known hypersensitivity to somatropin or any of the excipients

 -  Epiphyseal fusion

 -  Participation to any clinical study within the 30 days preceding study entry

 -  Pregnant females