Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants

Oak Hill Bio

Status: Terminated

Conditions: Chronic Lung Disease of Prematurity; Intraventricular Hemorrhage; Bronchopulmonary Dysplasia; Retinopathy of Prematurity (ROP)

Treatments: Other: No Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT04506619

SHP607-203

2020-002726-84 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 12 to 24 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants who were randomized into Study SHP607-202 (NCT03253263). Participants who were randomized, but did not complete Study SHP607-202 (NCT03253263) must be at least 12 months CA.
• Written informed consents (and assents, if applicable) must be signed and dated by the participant's parent(s)/legally authorized representative(s) prior to any study-related procedures. The informed consent and any assents for underage parents must be approved by the institutional review board (IRB)/independent ethics committee (IEC).

Exclusion criteria

• Participants are excluded from the study if the participant or participant's parent(s)/legally authorized representative(s) is/are unable to comply with the protocol or is/are unlikely to be available for long-term follow-up as determined by the investigator.

Trial design

26 participants in 3 patient groups

SHP607 250 mcg/kg/24 hours

Description:

Participants who received 250 micrograms per kilogram per 24 hours (mcg/kg/24 hours) in the previous study SHP607-202 (NCT03253263) will be followed into this long-term study SHP607-203.

Treatment:

Other: No Intervention

SHP607 400 mcg/kg/24 hours

Description:

Participants who received 400 mcg/kg/24 hours in the previous study SHP607-202 (NCT03253263) will be followed into this long-term study SHP607-203.

Treatment:

Other: No Intervention

Standard Neonatal Care

Description:

Participants who received standard neonatal care in the previous study SHP607-202 (NCT03253263) will be followed into this long-term study SHP607-203.

Treatment:

Other: No Intervention