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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00097513

Enrollment

Unknown

Registered

2004-11-25

Start date

2003-02-28

Completion date

2006-06-30

Last updated

2010-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dwarfism, Pituitary

Keywords

Pubertal Growth Hormone Deficiency

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

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

Countries

United States

Outcome results