National Cooperative Growth Study (NCGS): A Post-marketing Surveillance Program for Nutropin, Nutropin AQ, Nutropin Depot, and Protropin

Genentech

Status: Completed

Conditions: Growth Disorders

Treatments: Biological: Somatrem; Biological: Somatropin

Study type: Observational

Funder types: Industry

Identifiers

NCT00097539

85-036

Details and patient eligibility

About

The purpose of this multicenter, open-label, observational, post-marketing surveillance study is to collect long term safety and efficacy information on growth hormone (GH) products: Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) in the treatment of pediatric growth disorders for which GH is prescribed.

Enrollment: 65,205 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with open epiphyses
• Children of either sex who are treated with Nutropin Depot, Nutropin AQ, Nutropin, or Protropin for the treatment of growth failure
• Participants who are willing to keep follow up appointments throughout the study participation

Exclusion criteria

• Participants treated with a non-Genentech GH preparation
• Participants with closed epiphyses
• Participants with active neoplasia

Trial design

65,205 participants in 1 patient group

Participants With Growth Disorders

Description:

Participants initiating therapy with Genentech GH products: Protropin (somatrem for injection), Nutropin (somatropin for injection), Nutropin AQ (somatropin for injection), and Nutropin Depot (somatropin for injectable suspension) for the treatment of pediatric growth disorders as determined by their physician and who have consented to participate in the NCGS will be enrolled in the study and will be followed throughout their course of treatment, or until withdrawal from the NCGS.

Treatment:

Biological: Somatropin

Biological: Somatrem