Phase II Study of Growth Hormone in Children With Cystic Fibrosis - Tabular View

Tracking Information

First Received Date ^ICMJE

May 6, 2001

Last Updated Date

September 8, 2008

Start Date ^ICMJE

February 2001

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00016445 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Phase II Study of Growth Hormone in Children With Cystic Fibrosis

Official Title ^ICMJE

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment

Condition ^ICMJE

Cystic Fibrosis

Intervention ^ICMJE

Drug: growth hormone

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

August 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years to 12 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00016445

Responsible Party

Study ID Numbers ^ICMJE

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

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Dana S. Hardin

Southwest Medical Center at Dallas

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP