rhGH Therapy on Hepatic Drug Metabolism

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00458991
• Date of registration: 09/04/2007
• Prospective Registration: No
• Primary sponsor: University of Louisville
• Public title: rhGH Therapy on Hepatic Drug Metabolism
• Scientific title: Recombinant Human Growth Hormone Therapy and Drug Metabolism
• Date of first enrolment: June 2001
• Target sample size: 9
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00458991
• Study type: Observational
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Mary J Kennedy, PharmD
• Affiliation: Virginia Commonwealth University

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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



Age minimum: 4 Years
Age maximum: 14 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency, Dwarfism

Intervention(s)

Drug: Dextromethorphan and Caffeine

Secondary ID(s)

PPRU 10734

U10HD045934-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)