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

NCT ID: NCT00097552

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1696 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-05-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Turner Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Barbara Lippe, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Countries

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United States

Other Identifiers

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85-036, Substudy 9

Identifier Type: -

Identifier Source: org_study_id