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

Dwarfism, Pituitary Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00097513
• Other study ID #: 85-036, Substudy 12
• Status: Completed
• Phase: Phase 4
• First received: November 24, 2004
• Last updated: November 11, 2010
• Start date: February 2003
• Est. completion date: June 2006

Study information

• Verified date: November 2010
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 17 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dwarfism, Pituitary

Locations

Country	Name	City	State
United States	Genentech Central Contact	South San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States,