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A Study to Evaluate Subjects With Turner Syndrome Treated With Growth Hormone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00097552
Recruitment Status : Completed
First Posted : November 25, 2004
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Brief Summary:
This study is a multicenter, open-label, observational, postmarketing surveillance study of Genentech growth hormone (GH) products in the treatment of girls with Turner syndrome in the United States and Canada.

Condition or disease
Turner Syndrome

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Study Type : Observational
Actual Enrollment : 1696 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of Subjects With Turner Syndrome Treated With Growth Hormone in the National Cooperative Growth Study (NCGS)
Study Start Date : May 1997
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion Criteria:

  • Are girls with Turner syndrome who are being or will be treated with Nutropin, Nutropin AQ, or Protropin
  • Are willing to keep follow-up appointments throughout study participation
  • Are girls with Turner syndrome who have submitted Form 4 upon discontinuation and may also submit Form 9

Exclusion Criteria:

  • Have Noonan syndrome
  • Subjects treated within the last 6 months with a non-Genentech GH preparation
  • Have closed epiphyses prior to NCGS enrollment
  • Have active neoplasia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00097552


Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Barbara Lippe, M.D. Genentech, Inc.
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT00097552    
Other Study ID Numbers: 85-036, Substudy 9
First Posted: November 25, 2004    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012
Additional relevant MeSH terms:
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Turner Syndrome
Gonadal Dysgenesis
Syndrome
Disease
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases