Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
4 participants
OBSERVATIONAL
2017-01-12
2020-11-06
Brief Summary
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Detailed Description
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Exposed subjects are women who received Repatha® during pregnancy and/or breastfeeding; unexposed subjects are women who have not received Repatha® during pregnancy and/or breast-feeding. In infants, exposure may occur in utero and/or via breast milk, within 15 weeks following the date of Repatha® dosing in the mother
Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Repatha® exposed
Females with familial hypercholesterolaemia (FH) exposed to Repatha® in the 15 weeks prior to or during pregnancy or during breastfeeding
No interventions assigned to this group
Non exposed to Repatha®
Pregnant females with familial hypercholesterolaemia (FH) not exposed to Repatha® and enrolled into this study, overall and stratified by lipid lowering therapy use
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Confirmed pregnancy during the study observation period.
* Pregnancies identified retrospectively but within the study period will be included
* Multiple pregnancies, occurring in the same woman within the study period, will all be included (as separate pregnancies)
* Provided informed consent to follow-up in this study, for subject and their infant(s) born during the study observation period
FEMALE
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Camperdown, New South Wales, Australia
Research Site
Clayton, Victoria, Australia
Research Site
Graz, , Austria
Research Site
Aalst, , Belgium
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Edegem, , Belgium
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La Louvière, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Hradec Králové, , Czechia
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Liberec, , Czechia
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Prague, , Czechia
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Uherské Hradiště, , Czechia
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Aarhus N, , Denmark
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Athens, , Greece
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Heraklion, , Greece
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Ioannina, , Greece
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Piraeus, , Greece
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Cagliari, , Italy
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Cinisello Balsamo (MI), , Italy
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Ferrara, , Italy
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Genova, , Italy
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Messina, , Italy
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Milan, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Palermo, , Italy
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Perugia, , Italy
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Pisa, , Italy
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Roma, , Italy
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Amsterdam, , Netherlands
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Rotterdam, , Netherlands
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Oslo, , Norway
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Bratislava, , Slovakia
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Córdoba, Andalusia, Spain
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Málaga, Andalusia, Spain
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Zaragoza, Aragon, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Reus, Catalonia, Spain
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Malmo, , Sweden
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Uppsala, , Sweden
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Geneva, , Switzerland
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Reinach, , Switzerland
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Bournemouth, , United Kingdom
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Cambridge, , United Kingdom
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Manchester, , United Kingdom
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Peterborough, , United Kingdom
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Stevenage, , United Kingdom
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20150162
Identifier Type: -
Identifier Source: org_study_id