Phase II Study of Growth Hormone in Children With Cystic Fibrosis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 40
- Locations
- 9
Study Overview
Brief Summary
OBJECTIVES: I. Determine the effect of growth hormone on height, height velocity, body weight, and lean body mass in patients with cystic fibrosis.
II. Determine the effect of growth hormone on pulmonary function in these patients.
III. Determine the impact of this drug on the quality of life in these patients.
IV. Determine if the clinical response from this drug is sustained in these patients.
Detailed Description
PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
Arm I: Patients receive growth hormone subcutaneously (SC) daily for 1 year during the first year only.
Arm II: Patients receive growth hormone SC daily for 1 year during the second year only.
Quality of life is assessed at baseline and then every 6 months for 2 years.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 5 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •PROTOCOL ENTRY CRITERIA:
- •-Disease Characteristics--
- •Diagnosis of prepubertal cystic fibrosis
- •No colonization by Burkholderia cepacia
- •-Prior/Concurrent Therapy--
- •No prior or concurrent insulin requirement
- •-Patient Characteristics--
- •Hematopoietic: No hematologic disease
- •Hepatic: No liver disease
- •Renal: No kidney disease
- •Pulmonary: Must be able to perform pulmonary function testing
- •Other: No history of diabetes Must be less than 25% of normal height and/or weight for age and sex
Exclusion Criteria
- Not provided