Text Box: FIRST YEAR RESULTS OF FRENCH COLLABORATIVE STUDY IN YOUNG PATIENTS BORN WITH INTRA UTERINE GROWTH RETARDATION (I.U.RG.R.)TREATED WITH HIGHT DOSE OF GRANDITROPIN® (Liquid r-hGH) L.DI NICOLA1, P.CZERNICHOW2,D.SIMON2 C.GENDREL1, N.LE DREN1 P.RYZIGER1 1Grandis Biotech France SA, 2 (On behalf of the French Investigators ‘Group) Robert Debre Hospital " Departement of Paediatric Endocrinology " Paris, France We reports the preliminary results after 12 months in 14 (9 boys and 5 girls) young patients (between 2-4 years) with Intra Uterine Growth Retardation treated with hight dose of Granditropin® 5 mg (Liquid r-hGH) 0,60mg (1,8 IU) Kg/W Objective: Intra Uterine Growth Retardation is usually treated in France with a dose of 0,40 mg (1,2 IU)/ Kg/W during 3 years for girls between 3-8 years and for boys between 3-10 .The aim of the study is to optimise the catch up growth in very young I.U.R.G. patients (between 2-4 years hold).The most beneficial period therapy consisting on the first 2/3 years with height dose 0,60 mg (1,8 IU/Kg/W). Growth velocity, H.S.D.S. and metabolic parameters (Cholesterol, Glycaemia, Hb1AC, ASAT, ALAT, g GT) were evaluated before at one and two years therapy. Patients and Therapy: 14 patients (C.A. 3,9 ± 0,9 years) with short stature and growth retardation ³ -2,5 D.S. due to I.U.G.R. were included in our study they received during 2/3 years 0.60 mg (1,8 IU/Kg/W) Granditropin® 5 mg (15 IU) liquid formulation filled in cartridges 1,5 ml administered daily (SC) with GrandiPen® (BD). Results: Growth Velocity(cm/Y) H.S.D.S. Granditropin® (0,60 mg/Kg/W) C.A.(Years) T=0 T=12 T=0 T=12 DH.S.D.S N=14 3,9 ± 0,9 7,3 ± 1,0 11,4 ± 1,4 -3,2 ± 1,0 -1,8 ± 1,3 1,4±0,7 p<0,001 p<0,001 Conclusions : From preliminary study results we report than height velocity increased to be 11,4 ± 1,4 cm/Y (7,3 ± 1,0 cm/Y before treatment), H.S.D.S. was -3,2 ± 1,0 before treatment and -1,8 ± 1,3 after one year therapy with height dose delta H.S.D.S 1,4 ± 0,7. In the preliminary report of metabolic parameters (Cholesterol, AST, ALT, gGT, HB1AC) are not significantly modified by the dose. No serious adverse event correlated with GH dose administration was reported, local tolerance and compliance were also excellent. 1992