Main
|
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: |
|
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]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
|