Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)

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Brief Title

Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)

Official Title

Long-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

Brief Summary

      The main purpose of this study is to evaluate the long-term efficacy and safety outcomes
      following short-term exposure to rhIGF-1/rhIGFBP-3 versus standard neonatal care in Study
      ROPP-2008-01 (NCT01096784).
    

Detailed Description

      Long-term Safety and Efficacy Outcome Study Comparing Children Previously Enrolled in Study
      ROPP-2008-01 for the Prevention of Retinopathy of Prematurity (ROP)
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Number of Participants With Visual Acuity as Assessed by an Age-appropriate Method at 6 Months Corrected Age (CA)

Secondary Outcome

 Change From Baseline in Body Weight Z-score

Condition

Retinopathy of Prematurity (ROP)

Intervention

rhIGF-1/rhIGFBP-3

Study Arms / Comparison Groups

 Antecedent Standard of Care
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

76

Start Date

March 26, 2015

Completion Date

September 28, 2021

Primary Completion Date

September 28, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Participant was randomized in Study ROPP-2008-01 Section D (NCT01096784).

          -  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:

          -  Any other condition or therapy that, in the Investigator's opinion, may pose a risk to
             the Participant or interfere with the participants ability to be compliant with this
             protocol or interfere with the interpretation of results.

          -  The participant or participants parent or legally authorized representative(s) is
             unable to comply with the protocol as determined by the Investigator.
      

Gender

All

Ages

40 Weeks - 108 Weeks

Accepts Healthy Volunteers

No

Contacts

Study Director, , 

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT02386839

Organization ID

SHP607-201

Secondary IDs

2014-003556-31

Responsible Party

Sponsor

Study Sponsor

Shire


Study Sponsor

Study Director, Study Director, Takeda


Verification Date

April 2022