SHP607-203 Footsteps
Research type
Research Study
Full title
Long-Term Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment with SHP607 in Extremely Premature Infants
IRAS ID
286736
Contact name
Paul Clarke
Contact email
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
EudraCT Number, 2020-002726-84
Duration of Study in the UK
8 years, 5 months, 23 days
Research summary
This is long-term efficacy study. SHIRE/Takeda is the sponsor of this study.
The proposed study is a long-term safety and efficacy outcome study, following previously administered short-term treatment with SHP607 in extremely premature infants.
Low levels of insulin-like growth factor-1 (IGF-1) in extremely preterm infants (gestational age [GA] of 23 weeks +0 days to 27 weeks +6 days) are a risk factor for CRM \chronic respiratory morbidity) and other complications of extreme prematurity. Short-term administration of SHP607 may have long-lasting beneficial effects on safety and outcomes related to complications of prematurity. This non-interventional study will evaluate the long-term safety and efficacy outcomes of previously administered treatment with SHP607.
No investigational product will be administered in this study.
Approximately 477 participants who previously received SHP607 or standard neonatal care in Study SHP607-202 are planned to be enrolled in Study SHP607-203. Participants will be followed from 12 months CA through 5 years CA.
CRM will be assessed using pulmonary questionnaires, which will be administered to the parents or legally authorised representative(s) at regularly scheduled clinical site visits and telephone interviews through 5 years CA. Physical examinations will be performed at 12 months, 24 months, and 5 years CA. Additionally, AEs will be assessed to evaluate the long-term safety of SHP607.
A full list of procedures can be found on pages 17-18 of the protocol.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
22/YH/0127
Date of REC Opinion
22 Dec 2020
REC opinion
Further Information Favourable Opinion