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Current Clinical Trials with Authentic Recombinant Somatropin in Japan
Author(s) -
HIBI ITSURO,
TAKANO KAZUE,
SHIZUME KAZUO
Publication year - 1987
Publication title -
acta pædiatrica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.772
H-Index - 115
eISSN - 1651-2227
pISSN - 0803-5253
DOI - 10.1111/j.1651-2227.1987.tb17149.x
Subject(s) - medicine , somatropin , recombinant dna , surgery , pediatrics , gastroenterology , growth hormone , hormone , biochemistry , chemistry , gene
. Hibi, I., Takano, K. and Shizume, K. (National Children's Hospital and Tokyo Women's Medical College, Institute of Clinical Endocrinology, Tokyo, Japan). Current clinical trials with authentic recombinant somatropin in Japan. Acta Paediatr Scand [Suppl] 337:141, 1987. A total of 25 children with hGH deficiency were treated with recombinant somatropin, 0.5 IU/kg/week i.m. for approximately 12 months in a multicentre study. Sixteen patients were previousky untreated with any hGH preparation (naïve group) and 9 patients had been treated with pituitary hGH for 4–42 months (previously treated group). The height gain after 12 months with the present treatment was 7.7 ± 1.8 cm/year in the naive group and 5.8 ± 1.0 cm/year in the previously treated group. Using the criteria proposed by the Foundation for Growth Science in Japan, recombinant somatropin treatment was effective in 15 of 16 patients (93.8%) of the naive group and in all of the 9 patients (100%) in the switched group. Anti‐hGH antibody was observed in none of 9 patients in the previously treated group throughout the study period. It was observed in only 2 of 16 patients after 6 months of treatment and 1 of 16 patients after 12 months of treatment in the naïve group. No side‐effects or abnormalities in laboratory findings were observed.