Clinical Trial with Authentic Recombinant Somatropin in Japan

Abstract

Clinical trial with authentic recombinant somatropin in Japan. Acta Paediatr Scand [Suppl] 331: 18, 1987.Recombinant somatropin, produced by recombinant DNA technology, was administered by injection in daily doses of 8 IU to six healthy young volunteers. Daily injection for 4 days did not cause any significant change in the results of physical examination, blood count or urinalysis. Non-esterified fatty acid levels increased significantly from 0.45 f 0.16 to 1.08 ? 0.12 mEq/litre (mean k SEM) at 4 hours after the first injection (p<O.OOl). Plasma IGF-1 levels increased from 0.80 & 0.14 units/ml to 1.72 t 0.50,3.22 ? 1.02,3.17 t 1.20 and 3.63 t 0.78 units/ml at 24 hours after each daily injection for 4 days (p<O.OOl). Plasma hGH reached peak levels at 3 hours after intramuscular injection of recombinant somatropin, 4 IU, and this peak value was 57.3 t 2.8 ng/ml. A total of 21 patients with pituitary dwarfism were also treated with recombinant somatropin for 6 months at a dose of 0.5 IUkgiweek. Their heights increased by 2.25.0 cm during the 6 months of treatment, which was calculated to be equivalent to 4.4-10.0 cm/year with a mean growth rate of 7.4 ? 0.4 cdyear. Anti-hGH antibody with a titre of 10 was observed in two patients at the end of 6 months of treatment. Key words: Recombinant somalropin, pituitaty dwarfism, hCH deficiency, anti-hGH antibody.

Frequency of Growth Hormone in the Etiology of Short Stature and Treatment of the Deficient Cases With Exogenous Recombinant Growth Hormone

“…Çalışmamızın birinci yılı sonunda olgularımızda aldığımız büyüme cevabı, eksojen büyüme hormonunun lineer büyümeyi belirgin olarak artırdığını desteklemektedir. Çalışmamızda birinci yılda elde ettiğimiz büyüme hızlan hipofizer BH (hpBH), (metiyonlu BH}, (rhGH) kullanılan diğer çalışmalardaki sonuçlar ile uyıımludur (15,16,17,18). rhBH tedavisinin birinci yılındaki lineer büyüme hızlan değişik tedavi rejimleri uygulayan, değişik araştırıcılar tarafından farklılıklar göstermektedir.…”

Clinical Experience with Genotropin in Growth Hormone Deficient Children

“…Nineteen of the previously untreated patients had entered puberty at the time of inclusion. The inclusion criteria and the criteria for the diagnosis of G H deficiency were essentially the same in the different trials and have previously been reported (1)(2)(3)(4). There were 149 children (77%) with idiopathic G H deficiency; isolated GH deficiency was diagnosed in 116 patients (65%).…”

Clinical Experience with Genotropin Worldwide: An Update March 1987

“…For analysis of anti-hGH antibody formation, the combined group was divided into naive patients (134) and previously treated patients (65). The criteria for the diagnosis of hGH deficiency in the different trials have been reported earlier (2)(3)(4)(5). Pretreatment growth rates were available for the majority of the children and were based on a minimum of 6 months' observation.…”