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

Completed

• Conditions: Dwarfism, Pituitary

• Registration Number: NCT00097513
• Lead Sponsor: Genentech, Inc.

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 optimal GH dosing during puberty.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02
• Study First Submitted: 2004-11-24
• Study First Submitted QC: 2004-11-24
• Study First Posted: 2004-11-25
• Study Completion: 2006-06
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-11
• Last Update Posted: 2010-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Genentech Central Contact; 🇺🇸 South San Francisco, California, United States