Status:
COMPLETED
Optimization of the Dosage Regimen of Growth Hormone Therapy in Children Born Small for Gestational Age
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborating Sponsors:
Merck Serono S.A.S., an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Small Gestational Age (SGA)
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2007
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00249821
Start Date
February 28 2005
End Date
September 30 2007
Last Update
September 26 2017
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