A Postmarketing Surveillance Program for Nutropin, Nutropin AQ, and Protropin
Information source: Genentech
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Growth Disorders
Phase: Phase 4
Status: Recruiting
Sponsored by: Genentech Official(s) and/or principal investigator(s):
Barbara Lippe, M.D., Study Director, Affiliation: Genentech
Overall contact:
Trial Information Support Line, Phone: 800-723-6247
Summary
This study is a multicenter, open label, observational, postmarketing surveillance study of
Nutropin AQ, Nutropin, and Protropin in the United States and Canada. This study (and
subsequent substudies) were developed to investigate specific aspects of growth hormone (GH)
treatment.
Clinical Details
Official title: Genentech National Cooperative Growth Study (NCGS) Postmarketing Surveillance Program for Nutropin AQ [Somatropin (rDNA Origin) Injection], Nutropin [Somatropin (rDNA Origin) for Injection], and Protropin [Somatrem for Injection]
Study design: Cohort, Prospective
Eligibility
Minimum age: N/A.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children of either sex who are treated with Nutropin AQ, Nutropin, or Protropin for
the treatment of growth failure
- Subjects who are willing to keep follow up appointments throughout study
participation
Exclusion Criteria:
- Subjects treated with a non-Genentech GH preparation
- Subjects with closed epiphyses
- Subjects with active neoplasia
Locations and Contacts
Trial Information Support Line, Phone: 800-723-6247
Trial Information Support Line, South San Francisco, California 94080, United States; Recruiting
Phone: 800-723-6247
Additional Information
Starting date: October 1985
Ending date: December 2099
Last updated: July 14, 2008
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