rhGH Therapy on Hepatic Drug Metabolism

NCT00458991 | Completed

• 2 other identifiers: PPRU 10734U10HD045934-01
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of the study is to understand the effect of rhGH therapy on hepatic drug metabolism in children with idiopathic growth hormone deficiency.

Conditions

Growth Hormone Deficiency, Dwarfism

Keywords

Recombinant Human Growth Hormone; growth hormone deficiency; short stature; phenotyping

Interventions

Dextromethorphan and Caffeine DRUG

All subjects received standard medical therapy with rhGH and at specified times low doses of the pharmacologic "probes" (e.g., caffeine and dextromethorphan) as surrogate markers to determine CYP450 activity. The only direct treatment effect measured was the biological response to rhGH.

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children recently diagnosed with idiopathic GH deficiency who were candidates for rhGH therapy were eligible for enrollment. All subjects were recruited via informed parental consent and patient assent (for children \> 7 years). The anticipated sample size was 12 children.

You may qualify if:

• Children ages 4 to 14 years with a height less than the 5th percentile for age and sex or having a decelerated across two major percentiles (5th, 10th, 25th, 50th, 90th, and 95th) on standard pediatric growth curves, poor growth velocity (less than 5 centimeters/year), radiographic evidence of delayed bone age (i.e. greater than 1 SD below the mean for chronological age) and a documented diagnosis of idiopathic growth hormone deficiency \[as determined by failure to raise serum GH concentrations 10 microgram/Liter following provocative testing with two growth hormone secretagogues(e.g. insulin, arginine, or clonidine)\].
• All subjects will be prepubertal, as determined by Tanner staging.

You may not qualify if:

• Children receiving medications known to induce or inhibit hepatic CYP1A2, NAT-2, XO, CYP2D6 or CYP3A4 activity.
• Subjects with a history of smoking (including exposure to second hand smoke \> 8 hours per day) or illicit drug use.
• Subjects with a history of hepatic, renal, cardiac or thyroid disorders. Presence of hepatic, renal, cardiac or thyroid disease will be established based on clinical history and results of recent laboratory tests conducted as part of the routine medical evaluation of children who are being considered for rhGH therapy.
• Children experiencing fever or acute viral illness
• Children who have a history of a hypersensitivity reaction to dextromethorphan or caffeine
• Children who have received prior treatment with rhGH
• Children who are receiving corticosteroids or thyroid hormone

Sponsors & Collaborators

• University of Louisville: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (4)

University of California at San Diego

San Diego, California, 92103, United States

Location

Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, 40202, United States

Location

Children's Mercy Hospital and Clinics

Kansas City, Missouri, 64108, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106-6010, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary; Dwarfism

Interventions

Dextromethorphan; Caffeine

Condition Hierarchy (Ancestors)

Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring

Study Officials

• Mary J Kennedy, PharmD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2007
• First Posted: April 11, 2007
• Study Start: June 1, 2001
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

US (4)