A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis
This is a Phase II, multicenter, randomized, controlled, open-label trial of the safety and efficacy of Nutropin AQ administered subcutaneously (SC) daily in prepubertal children with CF and growth restriction.
Drug: Nutropin AQ [somatropin (DNA origin) injection]
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase II, Multicenter, Randomized, Controlled, Open-Label Study of the Safety and Efficacy of Nutropin AQ [Somatropin (DNA Origin) Injection] for the Treatment of Growth Restriction in Children With Cystic Fibrosis|
- To determine the safety and efficacy of Nutropin AQ in treating growth restriction and increasing lean body mass (LBM) in children with cystic fibrosis (CF) and growth restriction.
- To evaluate the effects of Nutropin AQ treatment on pulmonary function, disease-related exacerbations, and exercise tolerance in children with CF and growth restriction.
|Study Start Date:||September 2003|
|Study Completion Date:||May 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079742
|Study Director:||Barbara Lippe, M.D.||Genentech, Inc.|