Health Condition 1: null- idiopathic growth hormone deficiency
Conditions
Interventions
Intervention1: Zomacton: s.c. transjection One daily dose for 12 months
Control Intervention1: Genotropin: s.c. injection one daily dose for 12 months
Sponsors
Ferring Pharmaceuticals
Kendle India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Signed informed consent Children aged ≤3yrs old and not above 10 yrs for girls or 11 yrs for boys Idiopathic growth hormone deficiency confirmed during the pre-screening period by a standard GH stimulation test (defined as peak level of 10ng/ml pr lower if so required by the country specific board(s) Height SDS ≤2 SD of ref value for CA Height velocity SDSCA ≤ 0 SD of ref value for at least 6 months prior to pre-screening Height recorded for at least 6 months but not more than 18 months of pre-screening The difference between CA-BA≥ 1 A positive locally performed GH stimulation test (defined as a peak plasma level of ≤9ng/ml or lower if so required by the country specific board(s)) prior to the pre-screening
Exclusion criteria
Exclusion criteria: BA (Bone age) above 9 yrs for girls and 10 yrs for boys Puberty Tanner stage 1 Weight 12 Kg at screening Any prior treatment with GH Closed epiphysis Any diagnosed or suspected syndrome (e.g. Silver -Russell, Turners or seckel syndrome) which possibly could affect growth Any other diagnosed or suspected endocrine or metabolic disorder Any diagnosed or suspected sever chronic disease Clinical signs of dysmorphic features, malformations or mental retardations Growth failure due to other disorders Previous or present use of drugs that could interfere with GH treatment (e.g. steroids) Diagnosed malignant disease Any abnormal CS lab results that requires further investigation Receipt of an investigational drug within the last 28 days preceding screening or longer if considered possible to influence the outcome of the current trial Any knowledge of hypersensitivity to somatropin or any of the excipients of Zomacton or Genotropin
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Height VelocityTimepoint: 12 Months | — |
Secondary
| Measure | Time frame |
|---|---|
| Height SDS Height velocity SDS Change in IGF-1 and IGFBP-3 BA (Bone Age) Anti-hGH AB AE and tolerability CS Changes in safety lab, physical examination and vital signsTimepoint: 12 months | — |
Countries
Hungary, India, Israel, Poland, Romania, Russian Federation, Ukraine
Contacts
Public ContactMr Ataali Shaikh
Kendle India
Outcome results
None listed