Pituitary Gland |
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Clinical Trial: A Study to Evaluate Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone Deficiency (GHD) Subjects
This study is currently recruiting patients.
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Purpose
This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat GH-deficient subjects with optimal GH dosing during puberty.
| Condition | Phase |
|---|---|
| Dwarfism, Pituitary | Phase IV |
MedlinePlus related topics: Bone Diseases; Dwarfism; Pituitary Disorders
Study Type: Observational
Study Design: Natural History, Longitudinal, Defined Population, Prospective Study
Official Title: National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Subjects
Study start: February 2003; Expected completion: December 2099
Last follow-up: December 2099; Data entry closure: December 2099
Eligibility
Ages Eligible for Study: 12 Years - 17 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Adolescent boys who are GH deficient and Tanner Stage 2 or greater (testes 3 mL or greater)
- Adolescent girls who are GH deficient and breast Tanner Stage 2 or greater
- Current treatment with GH dose of 0.4 to 0.7 mg/kg/wk
- Ability to keep follow-up appointments throughout the study
- Willingness to remain on therapy until epiphyseal closure is achieved
- Prior enrollment in NCGS Core Study 85-036
Exclusion Criteria:
- Treatment with non-Genentech GH preparation
- Closed epiphyses
- Active neoplasia
- Treatment with insulin for diabetes
Location and Contact Information
California
Genentech Central Contact, South San Francisco, California, 94080, United States; Recruiting
More Information
Record last reviewed: March 2005
Last Updated: March 3, 2005
Record first received: November 24, 2004
ClinicalTrials.gov Identifier: NCT00097513
Health Authority: United States: Institutional Review Board (Awaiting confirmation)
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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