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.

Condition	Treatment or Intervention	Phase
Cystic Fibrosis	Drug: growth hormone	Phase II

Further Study Details: 

Expected Total Enrollment:  40

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.

Ages Eligible for Study:  5 Years   -   12 Years,  Genders Eligible for Study:  Both

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

Arizona
      Phoenix Children's Hospital, Phoenix,  Arizona,  85006,  United States
California
      Children's Hospital of Orange County, Orange,  California,  92868,  United States
Indiana
      James Whitcomb Riley Hospital for Children, Indianapolis,  Indiana,  46202-5225,  United States
Missouri
      Washington University, Saint Louis,  Missouri,  63110,  United States
Ohio
      Children's Medical Center - Dayton, Dayton,  Ohio,  45404,  United States
Oklahoma
      T.L. Carey, M.D. and Associates, Tulsa,  Oklahoma,  74136,  United States
Texas
      Cook Children's Medical Center - Fort Worth, Fort Worth,  Texas,  76104,  United States
      Southwest Medical Center at Dallas, Dallas,  Texas,  75390,  United States
Utah
      Primary Children's Medical Center, Salt Lake City,  Utah,  84113,  United States

Study chairs or principal investigators

Dana S. Hardin,  Study Chair,  Southwest Medical Center at Dallas   

Study ID Numbers:  199/15806; UUSOM-IRB-7797-00; GENENTECH-UUSOM-IRB-7797-00
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  May 6, 2001
ClinicalTrials.gov Identifier:  NCT00016445
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08