Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
NCT ID: NCT02386839
Last Updated: 2022-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2015-03-26
2021-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Antecedent Standard of Care
Participants who were treated with standard neonatal care in study ROPP-2008-01 (NCT01096784) were enrolled in this group for assessment of rhIGF-1/rhIGFBP-3 long-term efficacy and safety outcomes.
rhIGF-1/rhIGFBP-3
Participants who received "rhIGF-1/rhIGFBP-3" in study ROPP-2008-01 (NCT01096784) will be enrolled to this study. No investigational product will be administered in this study.
Antecedent rhIGF-1/rhIGFBP-3
Participants who were treated with rhIGF-1/rhIGFBP-3 in study ROPP-2008-01 (NCT01096784) were enrolled in this group for assessment of rhIGF-1/rhIGFBP-3 long-term efficacy and safety outcomes.
rhIGF-1/rhIGFBP-3
Participants who received "rhIGF-1/rhIGFBP-3" in study ROPP-2008-01 (NCT01096784) will be enrolled to this study. No investigational product will be administered in this study.
Interventions
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rhIGF-1/rhIGFBP-3
Participants who received "rhIGF-1/rhIGFBP-3" in study ROPP-2008-01 (NCT01096784) will be enrolled to this study. No investigational product will be administered in this study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants 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 participant.
Exclusion Criteria
* The participant or participants parent or legally authorized representative(s) is unable to comply with the protocol as determined by the Investigator.
40 Weeks
108 Weeks
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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University of South Alabama Children's and Women's Hospital
Mobile, Alabama, United States
Vidant Medical Center
Greenville, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
University of Wisconsin - Madison
Madison, Wisconsin, United States
Azienda Ospedaliera Universitaria Careggi
Florence, , Italy
Istituto Giannina Gaslini-Istituto Pediatrico di Ricovero e
Genova, , Italy
University of Padua
Padua, , Italy
Policlinico Universitario Agostino Gemelli
Roma, , Italy
VU Medical Center
Amsterdam, , Netherlands
Ginekologiczno-Położniczy Szpital Kliniczny Uniwersytetu Medycznego w Poznan
Poznan, , Poland
Skanes Universitetssjukhus Lund
Lund, , Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Addenbrookes Hospital
Cambridge, , United Kingdom
St Peter's Hospital
Chertsey, , United Kingdom
Alder Hey Childrens Hospital
Liverpool, , United Kingdom
UCL EGA Institute for Women's Health
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-003556-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SHP607-201
Identifier Type: -
Identifier Source: org_study_id
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