NCT02386839

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Shire · Industry
• Sex: All
• Age: 40 Weeks – 108 Weeks
• Healthy volunteers: Not accepted

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)

Conditions

• Retinopathy of Prematurity (ROP)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-03-26
• Primary completion: 2021-09-28
• Completion: 2021-09-28
• First posted: 2015-03-12
• Last updated: 2022-05-18
• Results posted: 2022-04-25

Locations

16 sites across 6 countries: United States, Italy, Netherlands, Poland, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study