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

Completed

• Conditions: Turner Syndrome

• Registration Number: NCT00097552
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 1997-05
• Study First Submitted: 2004-11-24
• Study First Submitted QC: 2004-11-24
• Study First Posted: 2004-11-25
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-13
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1696

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified