Phase II Study of Growth Hormone in Children With Cystic Fibrosis

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.

Completed

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Disease Attributes Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Respiratory Tract Diseases

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Phoenix Children's Hospital, Phoenix, Arizona, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

growth hormone

Drug

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start: 2001
Primary completion: 2007
First posted: May 7, 2001
Registry last updated: Sep 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed