Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

Long-term Phase IV Multicentre Study on the Safety and Efficacy of Omnitrope® (rhGH) in Short Children Born Small for Gestational Age (SGA)

This study is performed to investigate the long-term safety, in particular the diabetogenic potential and immunogenicity of rhGH therapy in short children born small for gestational age (SGA).

Prospective, open label, non-comparative, multicenter study. Short children born SGA were to be treated until they reached final height, but treatment could be discontinued earlier if medically indicated or if there was inadequate response to treatment.

Inclusion Criteria:

• Pre-pubertal (Tanner stage I) children born SGA Boys: 4 years of age or older Girls: 4 years of age or older
• Growth disturbance defined as current height SDS < -2.5 (and parental adjusted SDS <-1) for chronological age and sex according to country specific references.
• Birth weight and/or length below -2 standard deviations (SD) for gestational age

Exclusion Criteria:

• Onset of puberty
• Closed epiphyses
• Diabetes mellitus type I or type II
• Fasting blood glucose greater than 100 mg/dl or greater than 5.6 mmol/l measured in venous blood sample
• Abnormal findings in Oral Glucose Tolerance Test (OGTT) defined by greater than 140 mg/dl or greater than 7.8 mmol/l after 120 minutes
• Known IGF-I level above +2SD for sex and age
• Acute critical illness
• Previous treatment with any hGH preparation
• Treatment with antidiabetic medication (e.g. metformin, insulin)
• Drug abuse, substance abuse, or alcohol abuse