National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Patients

Completed

Conditions studied: Dwarfism, Pituitary

In brief

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 optimal GH dosing during puberty.

Key facts

Study ID

NCT00097513

Run by

Genentech, Inc.

Starts

2003-02-01

Expected to finish

2006-06-01

Last updated by the study team

2010-11-15

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Treatment with non-Genentech GH preparation
• Closed epiphyses
• Active neoplasia
• Treatment with insulin for diabetes

Where it is running

• Genentech Central Contact — South San Francisco, California, United States

Full record on ClinicalTrials.gov

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