Clinical trial NCT02906124: Study to Evaluate the Safety of Repatha® in Pregnancy
Official title: A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypercholesterolaemia
Pregnancy
Keywords: hypercholesterolaemia
Lipid lowering therapies
Pregnancy
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2016-09-19
Enrollment: 4
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sites in Europe, South Africa and Australia where pregnant familial hypercholesterolaemia (FH) Patients are treated with and without Repatha®

Brief summary: To evaluate pregnancy and infant outcomes among females diagnosed with familial hypercholesterolaemia (FH), exposed to Repatha® during pregnancy. This includes follow-up of their infants to the age of 12 months

Detailed description: Women diagnosed with familial hypercholesterolaemia (FH), treated at centres in Europe, South Africa and Australia, with pregnancy confirmed during the study observation period and who provide informed consent to participate in the study.

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

Eligibility criteria: Inclusion Criteria:

* Females diagnosed with Familial hypercholesterolaemia (FH).
* 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

Exclusion Criteria:

There are no exclusion criteria

Primary outcomes:
measure: Any incident of congenital anomaly
timeFrame: From birth up to 12 months of age
Secondary outcomes:
measure: End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth
timeFrame: From pregnancy diagnosis through to birth
measure: Status of infant at delivery
timeFrame: At delivery
measure: Details of any hospitalisations of infant, documented from delivery to 12 months of age.
timeFrame: From delivery to 12 months of age
measure: Mode of delivery of infant
timeFrame: At delivery
measure: Growth of infant at 6 months post delivery
timeFrame: Between birth and 6 months of age
measure: Details of any chronic medication taken by infant from birth to 12 months of age
timeFrame: From birth to 12 months of age
measure: Developmental milestones measured at 6 and 12 months of age
timeFrame: At 6 and 12 months of age of infant
measure: Details of any complication of delivery
timeFrame: At delivery
measure: Growth of infant at 12 months post delivery
timeFrame: Between birth and 12 months of age
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Research Site
state: New South Wales
city: Clayton
country: Australia
facility: Research Site
state: Victoria
city: Graz
country: Austria
facility: Research Site
city: Aalst
country: Belgium
facility: Research Site
city: Edegem
country: Belgium
facility: Research Site
city: La Louvière
country: Belgium
facility: Research Site
city: Leuven
country: Belgium
facility: Research Site
city: Liège
country: Belgium
facility: Research Site
city: Hradec Kralove
country: Czechia
facility: Research Site
city: Liberec
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Uherske Hradiste
country: Czechia
facility: Research Site
city: Aarhus N
country: Denmark
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Heraklion
country: Greece
facility: Research Site
city: Ioannina
country: Greece
facility: Research Site
city: Piraeus
country: Greece
facility: Research Site
city: Cagliari
country: Italy
facility: Research Site
city: Cinisello Balsamo (MI)
country: Italy
facility: Research Site
city: Ferrara
country: Italy
facility: Research Site
city: Genova
country: Italy
facility: Research Site
city: Messina
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Milano
country: Italy
facility: Research Site
city: Modena
country: Italy
facility: Research Site
city: Napoli
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Perugia
country: Italy
facility: Research Site
city: Pisa
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
state: Andalucía
city: Malaga
country: Spain
facility: Research Site
state: Andalucía
city: Zaragoza
country: Spain
facility: Research Site
state: Aragón
city: Hospitalet de Llobregat
country: Spain
facility: Research Site
state: Cataluña
city: Reus
country: Spain
facility: Research Site
state: Cataluña
city: Malmo
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
city: Geneva 14
country: Switzerland
facility: Research Site
city: Reinach
country: Switzerland
facility: Research Site
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Cambridge
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Peterborough
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: