CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Nutropin AQdrug
Likely dose
Nutropin AQ daily injection, dosage dependent on weightAI-extracted
Key inclusion· 1
  • Diagnosis of optic nerve hypoplasia (ONH), diagnosed at age ≤2 years
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00140413
NCT00140413Phase 4Completed

Endocrine Dysfunction and Growth Hormone Deficiency in Children With Optic Nerve Hypoplasia

Children's Hospital Los Angeles·interventional·Posted Sep 1, 2005·Updated Apr 1, 2015

In Brief

A Phase 4 clinical trial evaluating Nutropin AQ for Growth Hormone Deficiency and 2 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

Hypotheses: 1. The prevalence of endocrinopathies, and growth hormone (GH) deficiency in particular, among young children diagnosed with optic nerve hypoplasia (ONH) is higher than is commonly thought. 2. Early treatment of children with ONH and GH-deficiency can prevent adverse outcomes. Aims: 1. Determine the prevalence and types of endocrinopathies in children diagnosed with ONH. 2. Correlate endocrine outcome with radiographic, ocular, and developmental findings in children with ONH. 3. Examine the effect of GH treatment on growth and obesity in children with ONH, GH-deficiency, and either subnormal or normal growth compared to children with ONH that are not GH-deficient. 4. Compare growth outcomes between children with isolated GH-deficiency and those with multiple hormone deficiencies.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 1, 2005
Enrollment StartDec 1, 2004
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 20.8 years ago

Interventions

Nutropin AQdrug

Daily injection. Dosage dependent on weight.