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

Ferring Pharmaceuticals A/S0 个研究点目标入组 24 人开始时间: 2005年8月19日最近更新: 2012年3月19日

研究概览

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•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

•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

发起方