ong-term Outcome of Children Enrolled in Study ROPP-2008-01 Previously Treated with rhIGF-1/rhIGFBP-3 for the Prevention of Retinopathy of Prematurity (ROP) or Who Received Standard Neonatal Care

Premacure AB, A Member of the Shire Group of Companies0 sites120 target enrollmentJanuary 13, 2015

Overview

No summary available.

Registry

who.int

Start Date

January 13, 2015

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

Premacure AB, A Member of the Shire Group of Companies

•Each subject must meet the following criteria to be enrolled in this study.
•1\. Subject was randomized in Study ROPP\-2008\-01, Section D
•2\. Subject’s parent or legally authorized representative(s) must provide written informed consent prior to performing any study\-related activities. Study\-related activities are any procedures that would not have been performed during normal management of the subject.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 120
•F.1\.2 Adults (18\-64 years) no
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

•Subjects who meet any of the following criteria will be excluded from the study.
•1\. Any other condition or therapy that, in the Investigator’s opinion, may pose a risk to the
•subject or interfere with the subject’s ability to be compliant with this protocol or interfere
•with the interpretation of results
•2\. The subject or subject’s parent or legally authorized representative(s) is unable to comply
•with the protocol as determined by the Investigator