Status:
WITHDRAWN
Growth Hormone Treatment Study in Children With Cystic Fibrosis
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
5-12 years
Phase:
PHASE2
PHASE3
Brief Summary
Cystic fibrosis (CF) is a catabolic condition, and children affected with this disease frequently have problems with growth, despite adequate nutrition. We hypothesize that the anabolic effects of gro...
Detailed Description
We will test our hypotheses by recruiting 40 CF children from five CF centers (8 per center) across the country. Patients will be randomly assigned to receive treatment with GH (0.3 mg/kg/wk) during t...
Eligibility Criteria
Inclusion
- prepubertal CF patients (ages 5-12)
- capable of performing pulmonary function tests
- less than the 25th percentile for age and sex normal values for height and/or weight.
Exclusion
- previous diagnosis with diabetes
- previous insulin requirement
- inability to perform pulmonary function testing
- colonization with burkholderia cepacia
Key Trial Info
Start Date :
February 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 12 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00256555
Start Date
February 1 2000
End Date
December 12 2018
Last Update
January 10 2019
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