Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Information source: EMD Serono
Information obtained from ClinicalTrials.gov on October 19, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Small for Gestational Age
Intervention: Saizen (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: EMD Serono Official(s) and/or principal investigator(s):
Dominique ROGER, M.D., Study Director, Affiliation: Sponsor
Summary
Multicentric pilot comparative study, open-label, randomised, in parallel groups comparing one group of patients receiving 0. 057mg/kg/day (0. 40mg/kg/week) of Saizen® during 1 year to one group receiving 0. 035mg/kg/day (0. 24mg/kg/week) of Saizen® during 1 year after a 3-year treatment of r-hGH therapy with 0. 057mg/kg/day in both groups
Clinical Details
Official title:
Optimization of the Dosage Regimen With Growth Hormone Therapy in Children Born Small for Gestational Age. An Open Label, Randomized, Pilot Study, Comparing in Children Treated for 3 Years, the Efficacy of a Saizen® Treatment at the Same Dose Versus a Lower Maintenance Dose Prolonged During 1 Additional Year.
Study design: Interventional, Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Efficacy Study
Primary outcome: The efficacy will be assessed by the height gain expressed in cm/year and SDS/year during the fourth year.
Secondary outcome: Height velocity-Standard deviation Score, height and Height-S standard deviation Score. Local tolerance at the injection site, clinical tolerance and biological tolerance by assessing fasting glycemia, insulinemia, and Ultrasensitive TSH
Eligibility
Minimum age: 6 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
To be eligible for inclusion / randomisation into this study, the subjects must fulfil all of the following criteria (if there is no inclusion phase, the inclusion criteria will be considered as inclusion criteria for randomisation).
- Written consent form signed by the parents / legal guardian, and child if possible.
- Patient born SGA and receiving a r-hGH therapy for this pathology.
- r-hGH started at the maximal chronological age of 7 years for girls and 8 years for boys.
- Treatment with r-hGH started for at least 30 months and less than 36 months at 0. 057mg/kg/d
- Height gain during the first 2 years of GH treatment >1SD compared with the initial value.
Exclusion Criteria:
To be eligible for inclusion in this study the subjects must not meet any of the following criteria:
- Known hypersensitivity to Somatropin or any of the excipients.
- Active neoplasia (either newly diagnosed or recurrent).
- Intracranial hypertension
- Known diabetes mellitus
- Proliferative or preproliferative diabetic retinopathy
- Evidence of any progression or recurrence of an underlying intra-cranial space occupying lesion
- Obesity defined as degree 1 on the corpulence curves
- Precocious puberty
- Pubertal status: Tanner breast development stage >2 for girls, and testicular volume >4ml or testicular length >3cm and/or testosterone value >1nmol/l (0. 29g/ml) for boys.
For girls >9 years and Tanner breast development stage 1: uterine size > 35mm
- Severe chronic concomitant illness such as chronic renal failure, cystic fibrosis
- Concomitant corticoid treatment or levothyroxine treatment other than substitutive treatment, topical or inhaled treatment
- Participation to any clinical study within the 30 days preceding study entry.
Locations and Contacts
Local Medical Information Office, Paris, France
Additional Information
Full FDA approved prescribing information can be found here
Starting date:
February 2005
Ending date: September 2007
Last updated: June 11, 2007
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