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Sponsors and Collaborators: |
The University of Texas Health Science Center at San Antonio South Texas Veterans Health Care System Genentech |
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Information provided by: | The University of Texas Health Science Center at San Antonio |
ClinicalTrials.gov Identifier: | NCT00134420 |
We, the investigators at the University of Texas Health Science Center at San Antonio, want to learn if height and IQ (intelligence quotient) scores are improved by growth hormone (GH) treatment in children with chromosome 18 deletions and abnormal growth. Data from a previous study showed that growth hormone improved height in all children with 18q- and growth hormone deficiency. In addition, most of the study participants on growth hormone treatment showed an increase in IQ scores.
Condition | Intervention | Phase |
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Chromosome 18 Growth Hormone Deficiency |
Drug: Nutropin AQ Procedure: Arginine and Clonidine Stimulation Testing Procedure: Growth Factors Laboratory Testing Procedure: Neuropsychological Testing |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study |
Official Title: | Growth Hormone Trial for Children With 18q- and Abnormal Growth |
Estimated Enrollment: | 20 |
Study Start Date: | February 2001 |
Estimated Study Completion Date: | June 2005 |
Ages Eligible for Study: | up to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Texas | |
The University of Texas Health Science Center at San Antonio | |
San Antonio, Texas, United States, 78229-3900 |
Principal Investigator: | Daniel E. Hale, M.D. | The University of Texas Health Science Center at San Antonio |
Study ID Numbers: | 300-C07 |
Study First Received: | August 22, 2005 |
Last Updated: | July 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00134420 |
Health Authority: | United States: Food and Drug Administration |
Growth Hormone Chromosomes, Human, Pair 18 Child |
Dwarfism Bone Diseases, Endocrine Hypopituitary dwarfism Hypothalamic Diseases Pituitary Diseases Clonidine Central Nervous System Diseases Endocrine System Diseases |
Dwarfism, Pituitary Brain Diseases Bone Diseases Growth hormone deficiency Musculoskeletal Diseases Hypopituitarism Bone Diseases, Developmental Endocrinopathy |
Nervous System Diseases |