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.

Condition	Treatment or Intervention	Phase
Cystic Fibrosis	Drug: Nutropin AQ [somatropin (DNA origin) injection]	Phase II

Ages Eligible for Study:  5 Years   -   13 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Ability of parent or legal guardian to provide written informed consent and, if applicable, pediatric assent and compliance with study assessments for the full duration of the study
• Diagnosis of CF by sweat or genetic testing
• Between the ages of 5 and 12 years for girls and 5 and 13 years for boys
• Ability to perform pulmonary function tests in a reproducible manner, per American Thoracic Society guidelines for spirometry
• Height <10th percentile for age and sex
• Prepubertal, Tanner Stage 1
• Bone age of the non-dominant hand and wrist obtained no more than 6 months prior to study entry (bone age must be <10 years for girls and <11 years for boys as read using the method of Greulich and Pyle)
• Adequate caloric intake (following the CFF guidelines is encouraged)
• Normal thyroid function

Exclusion Criteria:

• Prior or current rhGH use
• History of short stature due to GHD
• History of glucose intolerance (impaired glucose tolerance) or CF related diabetes (CFRD)
• Infection with Burkholderia cepacia
• Qualitative change in antibiotic treatment (e.g., for exacerbation of lung infection) within 14 days of study entry
• Hospitalization or treatment with systemic corticosteroids during the 30 days prior to study entry
• Inability to adhere to previously documented adequate nutrition
• Active neoplasia
• Use of any investigational drug within 30 days of study enrollment
• Subjects who require, as part of the their medical care, scheduled elective hospitalizations for IV antibiotic therapy

Trial Information Support Line      800-662-6728 

Alaska
      Pediatric Breathing Disorders Clinic, Anchorage,  Alaska,  99508,  United States; Recruiting
Arkansas
      Pediatric and Pulmonology Research, Inc., Fort Smith,  Arkansas,  72903,  United States; Recruiting
California
      Kaiser Hospital, Oakland,  California,  94611,  United States; Recruiting
      Children's Hospital of Los Angeles, Los Angeles,  California,  90027,  United States; Recruiting
      University of California, San Diego, San Diego,  California,  92123,  United States; Recruiting
Florida
      Pediatric Pulmonary Associates, St. Petersburg,  Florida,  33701,  United States; Recruiting
      Nemours Children's Clinic, Pensacola,  Florida,  32504,  United States; Recruiting
      Nemours Children's Clinic, Orlando,  Florida,  32806,  United States; Recruiting
Illinois
      Chicago Cystic Fibrosis Specialists, Glenview,  Illinois,  60025,  United States; Recruiting
Massachusetts
      Boston Children's Hospital, Boston,  Massachusetts,  02115,  United States; Recruiting
Michigan
      University of Michigan Health System, Ann Arbor,  Michigan,  48109,  United States; Recruiting
Missouri
      Washington University, St. Louis,  Missouri,  63110,  United States; Recruiting
Nebraska
      University of Nebraska Medical Center, Omaha,  Nebraska,  68198,  United States; Recruiting
New Jersey
      Saint Peter's University Hospital, New Brunswick,  New Jersey,  08901,  United States; Recruiting
New York
      SUNY Health Science Center, Syracuse,  New York,  13210,  United States; Recruiting
North Carolina
      Duke Pediatric Clinical Research Program, Durham,  North Carolina,  27710,  United States; Recruiting
Ohio
      The Children's Medical Center, Dayton,  Ohio,  45401,  United States; Recruiting
      Children's Hospital Medical Center of Akron, Akron,  Ohio,  44308,  United States; Recruiting
      Cincinnati Children's Hospital Medical Center, Cincinnati,  Ohio,  45229,  United States; Recruiting
Oklahoma
      Baptist Medical Center, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
South Carolina
      Pediatric Pulmonary Associates, Columbia,  South Carolina,  29203,  United States; Recruiting
Texas
      University of Texas Health Center at Tyler, Tyler,  Texas,  75708,  United States; Recruiting
      Childrens Medical Center, Dallas,  Texas,  75235,  United States; Recruiting
Utah
      Intermountain Cystic Fibrosis Center, Salt Lake City,  Utah,  84113,  United States; Recruiting

Study ID Numbers:  L2762g
Record last reviewed:  April 2005
Last Updated:  April 6, 2005
Record first received:  March 11, 2004
ClinicalTrials.gov Identifier:  NCT00079742
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08