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

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.

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Key information

Conditions

Dwarfism, Pituitary Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Genentech Central Contact

South San Francisco, California, 94080, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2003
Study completion: 2006
First posted: Nov 25, 2004
Registry last updated: Nov 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed