rhGH Therapy on Hepatic Drug Metabolism

Completed

Conditions studied: Growth Hormone Deficiency, Dwarfism

In brief

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

Key facts

Study ID

NCT00458991

Run by

University of Louisville

People needed

9

Starts

2001-06-01

Expected to finish

2008-09-01

Last updated by the study team

2017-04-27

Who can join

Age: 4 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• University of California at San Diego — San Diego, California, United States
• Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
• Children's Mercy Hospital and Clinics — Kansas City, Missouri, United States
• Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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