Multicentre clinical trial of authentic recombinant somatropin in growth hormone deficiency.

A German multicentre trial of recombinant somatropin was commenced in March 1986. A total of 77 patients with hGH deficiency were recruited, with heights at least 2.5 SD below the normal mean. Of these, 49 were previously untreated (naïve) and 28 had previously received pituitary hGH. Recombinant somatropin, 12 IU/m2/week was administered subcutaneously, divided into six doses. In the naïve group, the height velocity reached 14.9 cm/year in the first 3 months, and thereafter stabilized at 12 cm/year. In the previously treated patients, the growth rate was 10.7 cm/year in the first 3 months, and 8.5 cm/year at 9 and 12 months. There were no abnormal findings in tests of laboratory parameters. No anti-hGH antibodies were detected in any of the patients; seven patients had anti-ECP antibodies, but in six of these the antibodies were already present before treatment.