drugset / Trial / NCT00287430

Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis

NCT00287430

Non-randomizedSingle-groupOpen-labelTreatment

Summary

We hypothesize that the anabolic effects of growth hormone (GH) will improve the clinical status of patients with CF by improving lean body mass, osteopenia, muscle strength, pulmonary function, and quality of life. We will recruit 40 malnourished CF patients for this 12-month study. All 40 patients will be treated with recombinant human growth hormone (rhGH). Each patient will serve as his/her own control by obtaining medical records for 6 months to 1 year prior to study enrollment or by completing 6 months of study without GH prior to being treated for 1 yr. with GH.

Timeline

Start
2006-01
Primary completion
2006-01
Completion
2006-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatropin Protein / enzyme biologic 0.0125 mg/kg Subcutaneous
Subject Somatropin Protein / enzyme biologic 0.025 mg/kg Subcutaneous
Subject Somatropin Protein / enzyme biologic 0.3 mg/kg Subcutaneous
Subject Somatropin Protein / enzyme biologic 0.6 mg/kg Subcutaneous

Indications