Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Small for Gestational Age (SGA)
Intervention: Saizen® (Drug); Saizen® (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck KGaA Official(s) and/or principal investigator(s): Laurence Fresneau, M.D., Study Director, Affiliation: Merck Serono S.A.S, France
Summary
Multicentric, open-label, randomized, pilot comparative study in parallel groups comparing 1
group of subjects receiving 0. 057 milligram/kilogram/day (mg/kg/day) or 0. 40 mg/kg/week of
Saizen® during 1 year to 1 group receiving 0. 035 mg/kg/day (0. 24 mg/kg/week) of Saizen®
during 1 year after an initial 3-year treatment of recombinant human growth hormone (r-hGH)
therapy with 0. 057 mg/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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Height Velocity
Secondary outcome: Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12Height Velocity-Standard Deviation Score (HV-SDS) Change From Baseline in Height at Month 6 Change From Baseline in Bone Age at Month 12 Insulin Like Growth Factor-1 (IGF-1) Levels Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Eligibility
Minimum age: 6 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
To be eligible for inclusion / randomization into this study, the subjects must fulfill
all of the following criteria (if there is no inclusion phase, the inclusion criteria will
be considered as inclusion criteria for randomization):
- Written consent form signed by the parents / legal guardian, and child if possible
- Subject born SGA and receiving a r-hGH therapy for this pathology
- Recombinant human growth hormone (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. 057
mg/kg/day
- Height gain during the first 2 years of GH treatment > 1 SD 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
> 4 milliliter (mL) or testicular length > 3 centimeter (cm) and/or testosterone
value >1 nanomole/liter [nmol/L] (0. 29 gram/mL [g/mL]) for boys For girls > 9 years
and Tanner breast development stage 1: uterine size > 35 millimeter (mm)
- 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
Additional Information
Related Info
Starting date: February 2005
Last updated: December 2, 2013
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