NCT00097552

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,696

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 1997

Longer than P75 for all trials

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

May 1, 1997

Completed
7.6 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
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

November 14, 2012

Status Verified

November 1, 2012

Enrollment Period

13.2 years

First QC Date

November 24, 2004

Last Update Submit

November 13, 2012

Conditions

Turner Syndrome

Eligibility Criteria

AgeUp to 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Turner Syndrome

Condition Hierarchy (Ancestors)

Gonadal DysgenesisDisorders of Sex DevelopmentUrogenital AbnormalitiesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesSex Chromosome Disorders of Sex DevelopmentMale Urogenital DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSex Chromosome DisordersChromosome DisordersGenetic Diseases, InbornGonadal DisordersEndocrine 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
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2004

First Posted

November 25, 2004

Study Start

May 1, 1997

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 14, 2012

Record last verified: 2012-11