Growth Hormone Deficiency Clinical Trial
Official title:
A Multicentre, Randomised, Open-label, Controlled Study to Evaluate the Effects of Saizen® on Cardiac Function in GHD Subjects During the Transition Phase From Childhood to Adulthood
This was a 48-week, open-label, prospective, multicentric, randomised, comparative with
parallel control, Phase 4 study to evaluate the effects of Saizen on cardiac function in GHD
subjects during the transition phase from childhood to adulthood.
The study was designed to evaluate whether recombinant-human growth hormone (r-hGH)
treatment also benefits young subjects with GHD. Some trials have already been published on
this subject, but they were mainly focused on the bone density.
Growth hormone is a 191 amino acid polypeptide hormone (MW 22,000) normally synthesised and
secreted by the somatotrophic cells of the anterior lobe of the pituitary gland. In normal
development, growth hormone and somatomedins are responsible for many of the manifestations
of normal growth and GHD is manifested by a marked short stature. Growth hormone deficiency
has been treated by human growth hormone for many years. Serono's r-hGH (Saizen) is produced
from genetically engineered mammalian cells.
The findings from previous clinical studies on GH treatment in GH-deficient adults,
collectively indicate that the majority of adults with long-standing GH deficiency, whether
dating from childhood or acquired in adult life, are compromised both physically and
psychologically and can derive clinical benefit from GH replacement. Based on observations
in the clinical trials to date , a GH dose of 0.01 mg/kg/day (50% of the dose used in
children), is likely to be satisfactory for many subjects. Moreover, it should be possible
to minimise early side effects, particularly fluid retention, by initiating treatment with
half of this dose and increasing to the final dose after 4 weeks if well tolerated.
In this study, it was proposed to enroll a group of childhood onset GHD subjects who were
not treated with r-hGH. Half of the study population started treatment for six months whilst
the other half remained on no r-hGH treatment. After six months the group already on r-hGH
therapy continued treatment for a further six months and the second group presently on no
r-hGH treatment started r hGH treatment for the remaining six months of the study.
OBJECTIVES
Primary objective:
- To compare the effects of Saizen on cardiac function (as assessed by percentage
ejection fraction) in subjects where 50% of the study population started r-hGH
treatment for 24 weeks and then remained on r-hGH treatment for a further 24 weeks and
subjects who continued on no r-hGH for 24 weeks before starting r-hGH for 24 weeks
during the transition phase from childhood to adulthood.
Secondary objectives:
- To assess the safety and tolerability of r-hGH in subjects who were transitioning from
childhood to adulthood, and to assess the change in body composition and lean body mass.
Subsidiary analyses of the other echocardiography parameters was also performed.
After entry into the trial, the subjects were randomised to one of two groups for a 48-week
period:
- Group 1: Saizen (r-hGH), 0.15-1.00 mg/day for 48 weeks, subcutaneous (s.c.)
- Group 2: No treatment for the first 24 weeks followed by Saizen (r-hGH)0.15-1.00 mg/day
for the next 24 weeks, s.c.
Subjects' visits to the study site was scheduled as follows:
- Group 1 - Baseline (study day 1), weeks 4, 12, 24, 36 & 48.
- Group 2 - Baseline (study day 1), weeks 12, 24, 28, 36 & 48. The study drug was
administered subcutaneously once daily in the evenings during the active treatment
period. The dose was to be adjusted stepwise, controlled by Insulin-Growth Factor-I
(IGF-I) values. The recommended final r-hGH dose was not to exceed 1.00mg/day
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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