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

Genentech

Status: Completed

Conditions: Dwarfism, Pituitary

Study type: Observational

Funder types: Industry

Identifiers

NCT00097513

85-036, Substudy 12

Details and patient eligibility

About

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.

Sex: All

Ages: 12 to 17 years old

Volunteers: No Healthy Volunteers

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