A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis

This study has been completed.
Sponsor:
Information provided by:
Genentech
ClinicalTrials.gov Identifier:
NCT00079742
First received: March 11, 2004
Last updated: June 5, 2008
Last verified: June 2008
  Purpose

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 Intervention Phase
Cystic Fibrosis
Drug: Nutropin AQ [somatropin (DNA origin) injection]
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • To evaluate the effects of Nutropin AQ treatment on pulmonary function, disease-related exacerbations, and exercise tolerance in children with CF and growth restriction.

Enrollment: 68
Study Start Date: September 2003
Study Completion Date: May 2007
  Eligibility

Ages Eligible for Study:   5 Years to 13 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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; caloric intake must be documented at screening using a 24-hour food diary)
  • Normal thyroid function

Exclusion Criteria:

  • Prior or current rhGH use
  • History of short stature due to GHD
  • History within the 12 months prior to screening of glucose intolerance (impaired glucose tolerance) or CF-related diabetes (CFRD) as defined by at least one of the following: fasting serum glucose of >= 126 mg/dL on two or more occasions; fasting serum glucose of >= 126 mg/dL plus any casual (previously called random) glucose level >= 200 mg/dL; casual (previously called random) glucose of >= 200 mg/dL on two or more occasions; fasting serum glucose of <= 126 mg/dL but 2-hour post oral glucose load of 140-199 mg/dL (impaired glucose tolerance) on two or more occasions; if a subject meets the criteria for impaired glucose tolerance or CFRD in the screening glucose tolerance test, even if there is no history of impaired glucose tolerance, the subject will not be eligible for the study.
  • 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
  • Participation in any other investigational study (including investigational drug studies) within 30 days of enrollment or during the study if in the treatment arm, except for participation in observational and questionnaire studies (untreated)
  • Subjects who require, as part of the their medical care, scheduled elective hospitalizations for IV antibiotic therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00079742

Sponsors and Collaborators
Genentech
Investigators
Study Director: Barbara Lippe, M.D. Genentech
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00079742     History of Changes
Other Study ID Numbers: L2762g
Study First Received: March 11, 2004
Last Updated: June 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Genentech:
Growth restriction in children with cystic fibrosis

Additional relevant MeSH terms:
Cystic Fibrosis
Fibrosis
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014