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Completed Phase 2 Interventional Results available

IGF-1/IGFBP3 Prevention of Retinopathy of Prematurity

ClinicalTrials.gov ID: NCT01096784

Public ClinicalTrials.gov record NCT01096784. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 4:07 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Determination of the rhIGF-1/rhIGFBP-3 Dose, Administered as a Continuous Infusion, Required to Establish and Maintain Longitudinal Serum IGF-1 Levels Within Physiological Levels in Premature Infants, to Prevent Retinopathy of Prematurity A Phase 2, Randomized Controlled, Assessor-blind, Dose Confirming, Pharmacokinetic, Safety and Efficacy, Multicenter Study

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

To compare the severity of retinopathy of prematurity (ROP) among treated infants with an untreated control population, matched for gestational age at birth while confirming the dose of rhIGF-1/rhIGFBP-3 is safe and efficacious.

Study identification

NCT ID
NCT01096784
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Shire
Industry
Enrollment
121 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Up to 1 Day
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 18, 2010 (Actual)
Primary completion
Mar 30, 2016 (Actual)
Completion
Mar 30, 2016 (Actual)
Last update posted
Jun 14, 2021

2010 – 2016

United States locations

U.S. sites
8
U.S. states
8
U.S. cities
8
Facility City State ZIP Site status
University of South Alabama Children's and Women's Hospital Mobile Alabama 36604-3391 —
Univ of California Irvine Med Center Irvine California 92697 —
Georgia Regents Medical Center Augusta Georgia 30904 —
Univ of Mississippi Medical Center Jackson Mississippi 39216-4505 —
Vidant Medical Center Greenville North Carolina 27834 —
University of Oklahoma Health Sciences Center Oklahoma City Oklahoma 73104 —
West Virginia University Hospital Morgantown West Virginia 26506 —
University of Wisconsin - Madison Madison Wisconsin 53715 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01096784, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 14, 2021 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01096784 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →