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National Cooperative Growth Study (NCGS) of Optimal Nutropin AQ and Nutropin Dosing in Pubertal Growth Hormone-Deficient (GHD) Patients

NCT ID: NCT00097513

Last Updated: 2010-11-15

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

Study Classification

OBSERVATIONAL

Study Start Date

2003-02-28

Study Completion Date

2006-06-30

Brief Summary

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This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech GH preparations to treat GH-deficient subjects with optimal GH dosing during puberty.

Detailed Description

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Conditions

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Dwarfism, Pituitary

Keywords

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Pubertal Growth Hormone Deficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Adolescent boys who are GH deficient and Tanner Stage 2 or greater (testes 3 mL or greater)
* Adolescent girls who are GH deficient and breast Tanner Stage 2 or greater
* Current treatment with GH dose of 0.4 to 0.7 mg/kg/wk
* Ability to keep follow-up appointments throughout the study
* Willingness to remain on therapy until epiphyseal closure is achieved
* Prior enrollment in NCGS Core Study 85-036

Exclusion Criteria

* Treatment with non-Genentech GH preparation
* Closed epiphyses
* Active neoplasia
* Treatment with insulin for diabetes
Minimum Eligible Age

12 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Genentech, Inc.

Principal Investigators

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Barbara Lippe, M.D.

Role: STUDY_DIRECTOR

Genentech, Inc.

Locations

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Genentech Central Contact

South San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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85-036, Substudy 12

Identifier Type: -

Identifier Source: org_study_id