Phase 3
N=22
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Small Gestational Age (SGA)
Bottom Line
View on ClinicalTrials.gov: NCT00249821 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Height Velocity — 6.40; 4.40 centimeter (cm)/year — p=0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Saizen® (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Merck KGaA, Darmstadt, Germany
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Height Velocity |
6.40; 4.40 | 0.001 sig |
| SECONDARY Change From Baseline in Height-Standard Deviation Score (H-SDS) at Month 6 and Month 12 |
-1.30; -1.50; 0.30; 0.10; 0.30; -0.10 | 0.012 sig |
| SECONDARY Height Velocity-Standard Deviation Score (HV-SDS) |
0.60; 0.10; 0.30; -0.10 | 0.022 sig |
| SECONDARY Change From Baseline in Height at Month 6 |
121.10; 119.20; 3.60; 2.50 | 0.029 sig |
| SECONDARY Change From Baseline in Bone Age at Month 12 |
7.50; 7.00; 1.40; 1.40 | 0.972 |
| SECONDARY Insulin Like Growth Factor-1 (IGF-1) Levels |
319.60; 275.40; 369.30; 262.40; 414.30; 263.00 | 0.058 |
| SECONDARY Insulin Like Growth Factor Binding Protein-3 (IGFBP-3) Levels |
3.40; 3.40; 3.00; 3.30; 3.60; 3.50 | 0.793 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
2; 1 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00249821). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.