Status:
COMPLETED
National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Patients
Lead Sponsor:
Genentech, Inc.
Conditions:
Dwarfism, Pituitary
Eligibility:
All Genders
12-17 years
Brief Summary
This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech GH preparations to treat GH-deficient subjects with optim...
Eligibility Criteria
Inclusion
- 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
- Treatment with non-Genentech GH preparation
- Closed epiphyses
- Active neoplasia
- Treatment with insulin for diabetes
Key Trial Info
Start Date :
February 1 2003
Trial Type :
OBSERVATIONAL
End Date :
June 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00097513
Start Date
February 1 2003
End Date
June 1 2006
Last Update
November 15 2010
Active Locations (1)
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1
Genentech Central Contact
South San Francisco, California, United States, 94080