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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 October 2017
Main ID:  NCT00140413
Date of registration: 31/08/2005
Prospective Registration: No
Primary sponsor: Children's Hospital Los Angeles
Public title: Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Scientific title: Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia
Date of first enrolment: December 2004
Target sample size: 20
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT00140413
Study type:  Interventional
Study design:   
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Mitchell Geffner, MD
Address: 
Telephone:
Email:
Affiliation:  Children's Hospital Los Angeles
Name:     Mark Borchert, MD
Address: 
Telephone:
Email:
Affiliation:  Childrens Hospital Los Angeles; University of Southern California
Key inclusion & exclusion criteria

Inclusion Criteria:

- New subjects diagnosed with ONH less than or equal to 2 years of age and subjects
actively enrolled (in currently approved prospective ONH study) will be eligible for
enrollment.



Age minimum: N/A
Age maximum: 5 Years
Gender: All
Health Condition(s) or Problem(s) studied
Growth Hormone Deficiency
Septo-Optic Dysplasia
Hypopituitarism
Intervention(s)
Drug: Nutropin AQ
Primary Outcome(s)
Change in Anthropometric Measures Over Time [Time Frame: Baseline and 36 months]
Secondary Outcome(s)
Secondary ID(s)
03.261
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Genentech, Inc.
Ethics review
Results
Results available: Yes
Date Posted: 01/04/2015
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT00140413
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