An Open-label, Multi-centre, Phase III Study of Local Tolerability of Zomacton 10 mg (Recombinant Somatropin) administered by ZomaJet Vision X

Conditions: 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.

Registration Number: EUCTR2005-001539-31-CZ

Lead Sponsor: Ferring Pharmaceuticals A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

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

• 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