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Phase II Study of Growth Hormone in Children With Cystic Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00016445
First Posted: May 7, 2001
Last Update Posted: September 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

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.


Condition Intervention Phase
Cystic Fibrosis Drug: growth hormone Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 40
Study Start Date: February 2001
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00016445


Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85006
United States, California
Children's Hospital of Orange County
Orange, California, United States, 92868
United States, Indiana
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, United States, 46202-5225
United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
United States, Ohio
Children's Medical Center - Dayton
Dayton, Ohio, United States, 45404
United States, Oklahoma
T.L. Carey, M.D. and Associates
Tulsa, Oklahoma, United States, 74136
United States, Texas
Southwest Medical Center at Dallas
Dallas, Texas, United States, 75390
Cook Children's Medical Center - Fort Worth
Fort Worth, Texas, United States, 76104
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
Sponsors and Collaborators
University of Utah
Investigators
Study Chair: Dana S. Hardin Southwest Medical Center at Dallas
  More Information

ClinicalTrials.gov Identifier: NCT00016445     History of Changes
Other Study ID Numbers: 199/15806
UUSOM-IRB-7797-00
GENENTECH-UUSOM-IRB-7797-00
First Submitted: May 6, 2001
First Posted: May 7, 2001
Last Update Posted: September 9, 2008
Last Verified: September 2008

Keywords provided by Office of Rare Diseases (ORD):
cardiovascular and respiratory diseases
cystic fibrosis
disease-related problem/condition
genetic diseases and dysmorphic syndromes
quality of life
rare disease

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs