Growth Hormone Treatment Study in Children With Cystic Fibrosis

NCT00256555 | Withdrawn Phase 2

• 1 other identifier: 999-M02
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Cystic fibrosis (CF) is a catabolic condition, and children affected with this disease frequently have problems with growth, despite adequate nutrition. We hypothesize that the anabolic effects of growth hormone (GH) will improve the height and weight of CF patients and thereby improve their clinical status and their quality of life. We further hypothesize that these effects will be sustained for at least one year after GH treatment is complete.

Conditions

Cystic Fibrosis

Interventions

Nutropin AQ DRUG

Eligibility Criteria

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

You may qualify if:

• prepubertal CF patients (ages 5-12)
• capable of performing pulmonary function tests
• less than the 25th percentile for age and sex normal values for height and/or weight.

You may not qualify if:

• previous diagnosis with diabetes
• previous insulin requirement
• inability to perform pulmonary function testing
• colonization with burkholderia cepacia

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Genentech, Inc.: collaborator

Related Publications (6)

• Hardin DS. GH improves growth and clinical status in children with cystic fibrosis -- a review of published studies. Eur J Endocrinol. 2004 Aug;151 Suppl 1:S81-5. doi: 10.1530/eje.0.151s081.

  PMID: 15339250 BACKGROUND

• Hardin DS. Growth hormone treatment in children with cystic fibrosis. Minerva Pediatr. 2002 Oct;54(5):365-71.

  PMID: 12244275 BACKGROUND

• Hardin DS. Growth problems and growth hormone treatment in children with cystic fibrosis. J Pediatr Endocrinol Metab. 2002 May;15 Suppl 2:731-5.

  PMID: 12092687 BACKGROUND

• Hardin DS, Ellis KJ, Dyson M, Rice J, McConnell R, Seilheimer DK. Growth hormone improves clinical status in prepubertal children with cystic fibrosis: results of a randomized controlled trial. J Pediatr. 2001 Nov;139(5):636-42. doi: 10.1067/mpd.2001.117578.

  PMID: 11713439 BACKGROUND

• Hardin DS, Ellis KJ, Dyson M, Rice J, McConnell R, Seilheimer DK. Growth hormone decreases protein catabolism in children with cystic fibrosis. J Clin Endocrinol Metab. 2001 Sep;86(9):4424-8. doi: 10.1210/jcem.86.9.7822.

  PMID: 11549686 BACKGROUND

• Hardin DS, Rice J, Ahn C, Ferkol T, Howenstine M, Spears S, Prestidge C, Seilheimer DK, Shepherd R. Growth hormone treatment enhances nutrition and growth in children with cystic fibrosis receiving enteral nutrition. J Pediatr. 2005 Mar;146(3):324-8. doi: 10.1016/j.jpeds.2004.10.037.

  PMID: 15756212 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Growth Hormone

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

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, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 00

Study Record Dates

• First Submitted: November 17, 2005
• First Posted: November 21, 2005
• Study Start: February 1, 2000
• Primary Completion: December 12, 2018
• Study Completion: December 12, 2018
• Last Updated: January 10, 2019

Record last verified: 2019-01