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Phase II Study of Growth Hormone in Children With Cystic Fibrosis

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
growth hormone
Sponsored by
University of Utah
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cardiovascular and respiratory diseases, cystic fibrosis, disease-related problem/condition, genetic diseases and dysmorphic syndromes, quality of life, rare disease

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Children's Hospital
  • Children's Hospital of Orange County
  • James Whitcomb Riley Hospital for Children
  • Washington University
  • Children's Medical Center - Dayton
  • T.L. Carey, M.D. and Associates
  • Southwest Medical Center at Dallas
  • Cook Children's Medical Center - Fort Worth
  • Primary Children's Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 6, 2001
Last Updated
September 8, 2008
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT00016445
Brief Title
Phase II Study of Growth Hormone in Children With Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Utah

4. Oversight

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cardiovascular and respiratory diseases, cystic fibrosis, disease-related problem/condition, genetic diseases and dysmorphic syndromes, quality of life, rare disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
growth hormone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dana S. Hardin
Organizational Affiliation
Southwest Medical Center at Dallas
Official's Role
Study Chair
Facility Information:
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
James Whitcomb Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5225
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
T.L. Carey, M.D. and Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Southwest Medical Center at Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase II Study of Growth Hormone in Children With Cystic Fibrosis

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