Phase II Study of Growth Hormone in Children With Cystic Fibrosis
NCT ID: NCT00016445
Last Updated: 2008-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2001-02-28
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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growth hormone
Eligibility Criteria
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Inclusion 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
5 Years
12 Years
ALL
No
Sponsors
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University of Utah
OTHER
Principal Investigators
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Dana S. Hardin
Role: STUDY_CHAIR
Southwest Medical Center at Dallas
Locations
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital of Orange County
Orange, California, United States
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, United States
Washington University
St Louis, Missouri, United States
Children's Medical Center - Dayton
Dayton, Ohio, United States
T.L. Carey, M.D. and Associates
Tulsa, Oklahoma, United States
Southwest Medical Center at Dallas
Dallas, Texas, United States
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States
Primary Children's Medical Center
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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UUSOM-IRB-7797-00
Identifier Type: -
Identifier Source: secondary_id
GENENTECH-UUSOM-IRB-7797-00
Identifier Type: -
Identifier Source: secondary_id
199/15806
Identifier Type: -
Identifier Source: org_study_id