Last updated on November 2017

A Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naive Growth Hormone-Deficient Children


Brief description of study

A Phase IV, Multicenter, Open-Label Study of the Immunogenicity of Nutropin AQ® V1.1 [Somatropin (rDNA Origin) Injection] Administered Daily to Naive Growth Hormone-Deficient Children

Detailed Study Description

This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naive to prior recombinant human growth hormone (rhGH) treatment. The study is designed to characterize the immunogenicity profile of Nutropin AQ v1.1 when administered as a daily subcutaneous (SC) injection for 12 months. The clinical impact of immunogenicity will also be assessed. The target sample size is 80 patients.

Clinical Study Identifier: TX6462

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Recruitment Status: Closed


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