Phase II Study of Growth Hormone in Children With Cystic Fibrosis

September 8, 2008 updated by: University of Utah

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Investigators

  • Study Chair: Dana S. Hardin, Southwest Medical Center at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

May 6, 2001

First Submitted That Met QC Criteria

May 4, 2001

First Posted (Estimate)

May 7, 2001

Study Record Updates

Last Update Posted (Estimate)

September 9, 2008

Last Update Submitted That Met QC Criteria

September 8, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 199/15806
  • UUSOM-IRB-7797-00
  • GENENTECH-UUSOM-IRB-7797-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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