drugset / Trial / 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)

NCT02386839 ↗

Phase 2 Completed 76 enrolled Shire
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2015-03-26
Primary completion
2021-09-28
Completion
2021-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject rhIGF-1/rhIGFBP-3 Unknown — —