Zomacton is indicated for the long term treatment of children who have growth failure due to inadequate secretion of growth hormone and for the long-term treatment of growth retardation due to Turner’s Syndrome confirmed by chromosome analysis.
Conditions
Interventions
Product Name: Zomacton 10 mg
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: Somatropin
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects between the ages of 3 and 17 years (both inclusive) with growth failure due to inadequate secretion of growth hormone or growth retardation due to Turner’s syndrome. Subjects have for a minimum of 6 months prior to study enrolment been receiving growth hormone therapy. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Closed epiphyses • Evidence of progression of an underlying intra-cranial lesion or other active neoplasms (inclusive leukaemia or solid tumours) within 1 year of treatment start • Acute critical illness suffering complications following open-heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure, or similar conditions • Any syndromes with an increased risk of chromosomal breakages and malignant diseases (e.g. Down’s syndrome, Bloom syndrome, Fanconi anaemia, neurofibromatosis-1) • Use of any non registered investigational drug within 3 months prior to screening or previous participation in the study • Pregnancy and lactation • Hypersensitivity to any excipients in Zomacton 10 mg and solvents to be used
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the local tolerability of an individualised dose of Zomacton 10 mg administered by ZomaJet Vision X;Secondary Objective: • To assess the frequency of local tolerability reactions when administering an individualised dose of Zomacton 10 mg by ZomaJet Vision X by local assessor • To assess the frequency of local tolerability reactions when administering an individualised dose of Zomacton 10 mg by ZomaJet Vision X by central assessor • To assess the frequency of immediate local reactions after administration of an individualised dose of Zomacton 10 mg by ZomaJet Vision X • To assess the subject’s evaluation of pain associated with transjection of an individualised dose of Zomacton 10 mg administered by ZomaJet Vision X • To assess the subject’s evaluation of itching associated with transjection of an individualised dose of Zomacton 10 mg administered by ZomaJet Vision X ;Primary end point(s): • The number of subjects discontinuing after treatment start due to unacceptable transjection related local tolerability reactions when receiving an individualised dose of Zomacton 10 mg administered by ZomaJet Vision X | — |
Countries
Czech Republic
Outcome results
None listed