A Study to Evaluate Subjects With Turner Syndrome Treated With Growth Hormone - Tabular View

Tracking Information

First Received Date ^ICMJE

November 24, 2004

Last Updated Date

July 14, 2008

Start Date ^ICMJE

May 1997

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00097552 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Characterization of Subjects With Turner Syndrome Treated With Growth Hormone in the National Cooperative Growth Study (NCGS)

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Turner Syndrome

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

December 2099

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

up to 17 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Trial Information Support Line

800-723-6247

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00097552

Responsible Party

Clinical Trials Posting Group, Genentech, Inc.

Study ID Numbers ^ICMJE

85-036, Substudy 9

Study Sponsor ^ICMJE

Genentech

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Barbara Lippe, M.D.

Genentech

Information Provided By

Genentech

Verification Date

July 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP