NCT00097513

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2003

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2006

Completed
Last Updated

November 15, 2010

Status Verified

November 1, 2010

First QC Date

November 24, 2004

Last Update Submit

November 11, 2010

Conditions

Dwarfism, Pituitary

Keywords

Pubertal Growth Hormone Deficiency

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Pubertal Growth Hormone Deficiency

You may qualify if:

  • 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

You may not qualify if:

  • Treatment with non-Genentech GH preparation
  • Closed epiphyses
  • Active neoplasia
  • Treatment with insulin for diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Genentech Central Contact

South San Francisco, California, 94080, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Condition Hierarchy (Ancestors)

DwarfismBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesBone Diseases, EndocrineHypopituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Study Officials

  • Barbara Lippe, M.D.

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 24, 2004

First Posted

November 25, 2004

Study Start

February 1, 2003

Study Completion

June 1, 2006

Last Updated

November 15, 2010

Record last verified: 2010-11

Locations

US(1)