Treatment of Children With Insufficient Secretion of Growth Hormone (BPLG-004)
Recruitment status was: Active, not recruiting
|Growth Hormone Deficiency (GHD)||Drug: growth hormone (somatropin)||Phase 3|
LG Life Sciences has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|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|
- Height velocity at the end of 12 months treatment [ Time Frame: 12 months ]
- 1.Height velocity SD score (HV SDS) after 12 months treatment, 2.Serum IGF-I levels3. Serum IGFBP-3 levels [ Time Frame: 12 months ]
|Study Start Date:||September 2005|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Experimental: LB03002, sustained release human hGH
Drug: growth hormone (somatropin)
dosing regimen is weight based.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271518
|United States, Pennsylvania|
|Division of Endocrinology, Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States|