Growth Hormone and Chromosome 18q- and Abnormal Growth

• Register: ClinicalTrials.gov
• Last refreshed on: 15 August 2016
• Main ID: NCT00134420
• Date of registration: 22/08/2005
• Prospective Registration: No
• Primary sponsor: The University of Texas Health Science Center at San Antonio
• Public title: Growth Hormone and Chromosome 18q- and Abnormal Growth
• Scientific title: Growth Hormone Trial for Children With 18q- and Abnormal Growth
• Date of first enrolment: February 2001
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00134420
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Daniel E. Hale, M.D.
• Affiliation: The University of Texas Health Science Center at San Antonio

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of chromosome 18 deletion (cytogenetics report)

- Children with abnormal growth but who are not classically growth hormone deficient

Exclusion Criteria:

- Children previously on growth hormone therapy



Age minimum: N/A
Age maximum: 18 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Loss of Chromosome 18q

Intervention(s)

Procedure: Arginine and Clonidine Stimulation Testing

Procedure: Growth Factors Laboratory Testing

Procedure: Neuropsychological Testing

Drug: Nutropin AQ

Primary Outcome(s)

growth rates 12-15 months after treatment begins

Secondary Outcome(s)

performance IQ scores 12-15 months after treatment begins

Secondary ID(s)

300-C07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

South Texas Veterans Health Care System

Genentech, Inc.