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:
Participant gender:
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
Details
Lead Sponsor:
Merck KGaA Merck KGaA, Darmstadt, Germany
Collaborator:
Merck Serono S.A.S., an affiliate of Merck KGaA, Darmstadt, Germany