Seven Years of Safety and Efficacy of the Recombinant Human Growth Hormone Omnitrope® in the Treatment of Growth Hormone Deficient Children: Results of a Phase III Study

Abstract

Aim: This phase III clinical study in growth hormone deficiency (GHD) children with growth retardation was designed to compare efficacy and safety of Omnitrope® with Genotropin® and assess the long-term safety and efficacy of Omnitrope®. The results of 7 years of treatment with Omnitrope® are presented. Patients and Methods: Eighty-nine treatment-naïve, prepubertal children with GHD were randomized (part 1) to Omnitrope® lyophilisate (group A, n = 44) or Genotropin® (group B, n = 45) for 9 months and received a subcutaneous dose of 0.03 mg/kg/day. In part 2, patients receiving Omnitrope® lyophilisate continued the same treatment for a further 6 months, while patients on Genotropin® were switched to Omnitrope® liquid for the subsequent 6 months. In part 3, patients in both groups received Omnitrope®liquid for a period up to 69 months. Results: The development of the 4 auxological parameters (height, height SD score, height velocity and height velocity SD score) and IGF-1 and IGFBP-3 levels were comparable between both groups of patients and confirmed the well-known growth response of GHD children to recombinant human GH treatment. Omnitrope® was well tolerated and safe over 7 years of treatment. Conclusion: The clinical comparability between Omnitrope® and Genotropin® was demonstrated within 9 months of treatment. Long-term safety and efficacy of 7 years of treatment with Omnitrope® was proven.