Current Clinical Trials with Authentic Recombinant Human Growth Hormone in Japan

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Abstract
Daily injections of methionine-free, recombinant hGH (rhGH), 8 IU, were administered in six healthy volunteers. Non-esterified fatty acid levels increased significantly from 0.45 +/- 0.06 to 1.08 +/- 0.05 mEq/litre (mean +/- SEM) at 4 hours after the first injection of rhGH (p less than 0.001). Plasma IGF-1 levels increased significantly at 24 hours after each of the four daily injections of rhGH (basal, 0.80 +/- 0.06 units/ml; 24 hours, 1.72 +/- 0.21 units/ml; 48 hours, 3.22 +/- 0.42 units/ml; 72 hours, 3.17 +/- 0.49 units/ml; 96 hours, 3.63 +/- 0.32 units/ml; p less than 0.001). Eleven patients with hGH deficiency were treated with rhGH, 0.5 IU/kg/week for 3 months. Their heights increased by between 1.1 cm and 4.1 cm during the 3 months of treatment, which was calculated to be equivalent to 4.4-16.4 cm/year, with a mean height velocity of 8.6 +/- 1.1 cm/year. Anti-hGH antibody was observed in one patient treated with rhGH and had a titre of 10.