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

  • STATUS
    Not Recruiting
  • sponsor
    Genentech, Inc.
Updated on 21 April 2022

Summary

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

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.

Details
Condition Growth Hormone Deficiencies/Abnormalities
Clinical Study IdentifierTX140484
SponsorGenentech, Inc.
Last Modified on21 April 2022

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