|E.1 Medical condition or disease under investigation
|Medical condition(s) being investigated
|Idiopathic growth hormone deficiency.
|E.1.2 Medical condition or disease under investigation
|Growth hormone deficiency
|Condition being studied is a rare disease
|E.2 Objective of the trial
|Main objective of the trial
|To demonstrate that one daily dose of ZOMACTON (10 mg/mL) is equivalent to one daily dose of GENOTROPIN (12 mg/mL) in terms of growth measured as height velocity based on 12 months of treatment.
|Secondary objectives of the trial
|1. To investigate the efficacy of one daily dose of ZOMACTON compared with one daily dose of GENOTROPIN measured as an increase in height SDS during 12 months of treatment.
2. To investigate the efficacy of one daily dose of ZOMACTON compared with one daily dose of GENOTROPIN measured as an increase in height velocity SDS during 12 months of treatment.
3. To investigate the effect of ZOMACTON versus GENOTROPIN on the serum levels of IGF-1 and IGFBP-3 during 12 months as compared to baseline.
4.To investigate the Δbone age (ΔBA) at 12 months as compared to baseline for ZOMACTON versus GENOTROPIN.
5.To investigate the safety of treatment of ZOMACTON as compared to GENOTROPIN (safety lab, frequency and severity of adverse events, immunogenicity)
|Trial contains a sub-study
|Principal inclusion criteria
|Inclusion criteria Pre-screening:
1.Signed informed consent and obtained assent.
2.Children aged ≥ 3 years and not above 10 years for girls or 11 years for boys at the Pre-screening visit.
3.A positive locally performed GH stimulation test (defined as peak plasma level of < 9 ng/mL or lower if so required by the country specific board(s)) prior to the Pre-screening visit.
4.Height SDS < -2 SD of reference value for chronological age (CA)
5.Height velocity SDSCA ≤ 0 SD of reference value for at least 6 months prior to the Pre-screening visit
6.Height recorded for at least 6 months but performed no more than 18 months before the Pre-screening visit.
Inclusion criteria Screening:
7.Reconfirmed signed informed consent and obtained assent
8.The difference between CA-BA ≥ 1.
9.Idiopathic GH deficiency confirmed during the Pre-screening period by a standard GH stimulation test (defined as peak plasma level of < 9 ng/mL or lower if so required by the country specific board(s))
|Principal exclusion criteria
|Exclusion criteria Pre-screening:
1.Any prior treatment with GH
2.Any diagnosed or suspected syndrome (e.g. Silver-Russell, Turner’s or Seckel syndrome) which possibly could affect growth
3.Any other diagnosed or suspected endocrine or metabolic disorder (e.g. Prader-Willi syndrome, diabetes mellitus or Cushing’s syndrome)
4.Any diagnosed or suspected severe chronic disease
5.Clinical signs of dysmorphic features, malformations or mental retardation
6.Growth failure due to other disorders (emotional deprivation, severe chronic illness, malnutrition or chondrodysplasia)
7.Previous or present use of drugs that could interfere with GH treatment (e.g. steroids)
8.Diagnosed malignant disease
9.Any known hypersensitivity to somatropin or any of the excipients of ZOMACTON and GENOTROPIN.
Exclusion criteria Screening:
10.BA above 9 years in girls and above 10 years in boys (to exclude pubertal growth)
11.Puberty Tanner Stage > I
12.Weight < 12 kg at the Screening visit
14.Any abnormal clinically significant lab results that requires further investigation
15.Receipt of an investigational drug within the last 28 days preceding Screening or longer if considered to possibly influence the outcome of the current trial.
|E.5 End points
|Primary end point(s)
|1. Height velocity based on the 12 months treatment period.
|E.6 and E.7 Scope of the trial
|Scope of the trial
|Other scope of the trial description
|Trial type and phase
|Human pharmacology (Phase I)
|First administration to humans
|Other trial type description
|Phase III biosimilar trial
|Therapeutic exploratory (Phase II)
|Therapeutic confirmatory (Phase III)
|Therapeutic use (Phase IV)
|E.8 Design of the trial
| Comparator of controlled trial
|Other medicinal product(s)
The trial involves single site in the Member State concerned
| The trial involves multiple sites in the Member State concerned
|Number of sites anticipated in Member State concerned
|The trial involves multiple Member States
|Number of sites anticipated in the EEA
|E.8.6 Trial involving sites outside the EEA
|Trial being conducted both within and outside the EEA
|Trial being conducted completely outside of the EEA
| Information not present in EudraCT
|If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
|Trial has a data monitoring committee
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|When the last ongoing patient in the trial attends the End of Trial Visit (as in protocol)
|E.8.9 Initial estimate of the duration of the trial
|In the Member State concerned years
|In the Member State concerned months
|In the Member State concerned days
|In all countries concerned by the trial years
|In all countries concerned by the trial months
|In all countries concerned by the trial days