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

Genentech, Inc.

Overview

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.

Study Type

OBSERVATIONAL

Conditions

Dwarfism, Pituitary

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (1)

Genentech Central Contact

South San Francisco, California, United States

Data from ClinicalTrials.gov

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