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

NCT02386839 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2022-05-18

Study results available
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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).

Conditions

  • Retinopathy of Prematurity (ROP)

Interventions

DRUG

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.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Weeks
Max Age
108 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-26
Primary Completion
2021-09-28
Completion
2021-09-28
FDA Drug
Yes

Countries

  • United States
  • Italy
  • Netherlands
  • Poland
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02386839 on ClinicalTrials.gov