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

Phase 3 Completed 22 enrolled Merck KGaA, Darmstadt, Germany Merck Serono S.A.S., an affiliate of Merck KGaA, Darmstadt, Germany · collab

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2005-02-28
Primary completion: 2007-09-30
Completion: 2007-09-30

Outcome

Met primary endpoint

paper Children who continued receiving 57 μg/kg/day r-hGH in year 4 had significantly greater height gain than those receiving 35 μg/kg/day r-hGH. PMID 22508151 ↗

registry Saizen® 0.057 mg/kg/Day vs Saizen® 0.035 mg/kg/Day; p = 0.001; ANCOVA NCT00249821 ↗

Publications

Results Chatelain P, Colle M, Nako JP, Le Luyer B, Wagner K, Berlier P, Tauber M. Optimization of growth hormone dosing in children born small for gestational age: an open-label, randomized study of children during the fourth year of therapy. Horm Res Paediatr. 2012;77(3):156-63. doi: 10.1159/000337216. Epub 2012 Apr 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Somatropin	Protein / enzyme biologic	0.035 mg/kg	—
Subject	Somatropin	Protein / enzyme biologic	0.057 mg/kg	—