Phase II Study of Growth Hormone in Children With Cystic Fibrosis

NCT00016445 | Completed Phase 2

• 3 other identifiers: 199/15806UUSOM-IRB-7797-00GENENTECH-UUSOM-IRB-7797-00
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 9

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.

Conditions

Cystic Fibrosis

Keywords

cardiovascular and respiratory diseases; cystic fibrosis; disease-related problem/condition; genetic diseases and dysmorphic syndromes; quality of life; rare disease

Interventions

growth hormone DRUG

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Utah: lead

Study Sites (9)

Phoenix Children's Hospital

Phoenix, Arizona, 85006, United States

Location

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

James Whitcomb Riley Hospital for Children

Indianapolis, Indiana, 46202-5225, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Children's Medical Center - Dayton

Dayton, Ohio, 45404, United States

Location

T.L. Carey, M.D. and Associates

Tulsa, Oklahoma, 74136, United States

Location

Southwest Medical Center at Dallas

Dallas, Texas, 75390, United States

Location

Cook Children's Medical Center - Fort Worth

Fort Worth, Texas, 76104, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Respiratory Tract Diseases; Genetic Diseases, Inborn; Rare Diseases

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dana S. Hardin

  Southwest Medical Center at Dallas

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2001
• First Posted: May 7, 2001
• Study Start: February 1, 2001
• Primary Completion: August 1, 2007
• Last Updated: September 9, 2008

Record last verified: 2008-09

Locations

US (9)