Status:
COMPLETED
Follow up Study to Assess Long Term Safety and Outcomes in Infants and Children Born to Mothers Participating in Retosiban Treatment Studies
Lead Sponsor:
GlaxoSmithKline
Collaborating Sponsors:
PPD Development, LP
Conditions:
Obstetric Labour, Premature
Eligibility:
All Genders
10-20 years
Phase:
PHASE3
Brief Summary
The primary objective of this study is to assess the safety and outcomes of infants and children who were exposed to retosiban or comparator in utero in the Phase III spontaneous preterm labor (SPTL) ...
Eligibility Criteria
Inclusion
- Mother is randomly assigned and dosed (retosiban or comparator) in 1 of the Phase III SPTL retosiban clinical studies.
- Infant is alive at 28 days post EDD.
- Written informed consent is obtained from the parent(s) or legal guardian(s) of the infant. The parent/legal guardian of subjects aged 12 to 17 years must also provide written agreement for the infant to participate in the study where required by applicable regulatory and country or state requirements.
Exclusion
- There are no formal exclusion criteria for participation.
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 2 2019
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT02292784
Start Date
June 1 2015
End Date
September 2 2019
Last Update
July 9 2020
Active Locations (26)
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1
GSK Investigational Site
Park Ridge, Illinois, United States, 60068
2
GSK Investigational Site
Galveston, Texas, United States, 77555-0587
3
GSK Investigational Site
Ghent, Belgium, 9000
4
GSK Investigational Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106