Trials / Terminated
TerminatedNCT04506619
Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
Long-Term Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 26 (actual)
- Sponsor
- Oak Hill Bio Ltd · Industry
- Sex
- All
- Age
- 12 Months – 24 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.
Detailed description
In this long-term follow-up study, participants who enrolled in SHP607-202 (NCT03253263) will be followed from 12 months corrected age (CA) through 60 months CA. Participants will not receive any investigational product in this study.
Conditions
- Retinopathy of Prematurity (ROP)
- Intraventricular Hemorrhage
- Bronchopulmonary Dysplasia
- Chronic Lung Disease of Prematurity
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No Intervention | This is a non-interventional study. |
Timeline
- Start date
- 2020-09-09
- Primary completion
- 2022-08-05
- Completion
- 2022-08-05
- First posted
- 2020-08-10
- Last updated
- 2023-03-24
Locations
8 sites across 3 countries: United States, Italy, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04506619. Inclusion in this directory is not an endorsement.