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Clinical Trials/EUCTR2014-003556-31-SE
EUCTR2014-003556-31-SE
Active, not recruiting
Phase 1

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 enrollmentDecember 22, 2014
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ConditionsRetinopathy of Prematurity (ROP)Therapeutic area: Body processes [G] - Ocular Physiological Phenomena [G14]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Retinopathy of Prematurity (ROP)
Sponsor
Premacure AB, A Member of the Shire Group of Companies
Enrollment
120
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 22, 2014
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Premacure AB, A Member of the Shire Group of Companies

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

Not specified

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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 CareRetinopathy of prematurityROP10047060
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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
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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
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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
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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
EUCTR2014-003556-31-ITPREMACURE AB, A MEMBER OF SHIRE GROUP OF COMPANIES76