Status:

COMPLETED

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

Lead Sponsor:

Genentech, Inc.

Conditions:

Growth Disorders

Eligibility:

All Genders

Brief Summary

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 (somatr...

Eligibility Criteria

Inclusion

  • 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

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

Key Trial Info

Start Date :

October 1 1985

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 1 2010

Estimated Enrollment :

65205 Patients enrolled

Trial Details

Trial ID

NCT00097539

Start Date

October 1 1985

End Date

June 1 2010

Last Update

February 15 2017

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