Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age

• Status: Completed
• Trial end date: 2007-09-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck KGaA; Merck KGaA, Darmstadt, Germany
• Collaborator: Merck Serono S.A.S., an affiliate of Merck KGaA, Darmstadt, Germany
• Treatments: Hormones

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