Growth Hormone Deficiency (GHD) Clinical Trial
Official title:
A Phase III, Multi-centre, Randomised, Parallel Group Study of Safety and Efficacy of the LB03002 a New Sustained Release Formulation of Human Recombinant Growth Hormone as Compared to Standard Daily Therapy in Treatment Naive Children With Growth Failure Due to Insufficient Secretion of Endogenous Growth Hormone
The purpose of this study is to compare a new weekly administered growth hormone preparation with standard daily treatment in children with insufficient secretion of growth hormone
Treatment with recombinant human growth hormone (somatropin) has been proven to be effective
in stimulating height velocity and improving height in children with short stature due to
insufficient endogenous Growth Hormone secretion. Currently somatropin is available in daily
injection formulations. The requirement of daily administration causes significant burden
and interruption of normal daily life. A product with less frequent dosing regimen will
provide considerable improvement over currently available conventional replacement therapy
regimens.
The primary objective of this study is to demonstrate the clinical comparability in terms of
safety and efficacy of a new sustained release recombinant human growth hormone formulation
to that of daily growth hormone.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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