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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02906124
Registration number
NCT02906124
Ethics application status
Date submitted
1/08/2016
Date registered
19/09/2016
Date last updated
22/12/2020
Titles & IDs
Public title
Study to Evaluate the Safety of Repatha® in Pregnancy
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Scientific title
A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy
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Secondary ID [1]
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20150162
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolaemia
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Pregnancy
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Condition category
Condition code
Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Repatha® exposed - Females with familial hypercholesterolaemia (FH) exposed to Repatha® in the 15 weeks prior to or during pregnancy or during breastfeeding
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
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Any incident of congenital anomaly
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Assessment method [1]
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Any incidence of congenital anomaly recorded on the study specific eCRF
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Timepoint [1]
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From birth up to 12 months of age
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Secondary outcome [1]
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End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth
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Assessment method [1]
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Live birth(s), still birth, spontaneous loss, elective termination, ectopic pregnancy, complication of pregnancy (pre-eclampsia, gestational diabetes)
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Timepoint [1]
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From pregnancy diagnosis through to birth
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Secondary outcome [2]
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Status of infant at delivery
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Assessment method [2]
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Collection of data on gender; gestational age; Apgar score and birth weight
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Timepoint [2]
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At delivery
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Secondary outcome [3]
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Details of any hospitalisations of infant, documented from delivery to 12 months of age.
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Assessment method [3]
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Collection of hospitalisation reason, admission and discharge dates.
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Timepoint [3]
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From delivery to 12 months of age
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Secondary outcome [4]
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Mode of delivery of infant
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Assessment method [4]
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Collection of delivery mode classified by caesarian section, normal vaginal delivery, operative vaginal delivery and vaginal breech delivery
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Timepoint [4]
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At delivery
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Secondary outcome [5]
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Growth of infant at 6 months post delivery
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Assessment method [5]
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Data on infant growth measured by weight in kilograms.
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Timepoint [5]
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Between birth and 6 months of age
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Secondary outcome [6]
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Details of any chronic medication taken by infant from birth to 12 months of age
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Assessment method [6]
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Details of any chronic medication prescribed to infant from birth to 12 months of age
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Timepoint [6]
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From birth to 12 months of age
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Secondary outcome [7]
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Developmental milestones measured at 6 and 12 months of age
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Assessment method [7]
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A check of developmental milestones made at 6 and 12 months of age. Details collected where expected milestones were not met.
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Timepoint [7]
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At 6 and 12 months of age of infant
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Secondary outcome [8]
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Details of any complication of delivery
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Assessment method [8]
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Recording the occurence of any complications of delivery as listed; requirement for blood transfusion, thromboembolism, fetal distress and amniotic fluid abnormality
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Timepoint [8]
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At delivery
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Secondary outcome [9]
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Growth of infant at 12 months post delivery
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Assessment method [9]
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Data on infant growth measured by weight in kilograms.
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Timepoint [9]
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Between birth and 12 months of age
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Eligibility
Key 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
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
There are no exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/11/2020
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Sample size
Target
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Accrual to date
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Final
4
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Research Site - Camperdown
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Recruitment hospital [2]
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Research Site - Clayton
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment outside Australia
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Austria
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State/province [1]
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Graz
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Belgium
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Aalst
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Belgium
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Edegem
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Belgium
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La Louvière
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Belgium
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Leuven
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Belgium
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Liège
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Czechia
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Hradec Kralove
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Czechia
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Liberec
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Czechia
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Praha 2
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Czechia
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Uherske Hradiste
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Denmark
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Aarhus N
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Greece
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Athens
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Greece
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Heraklion
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Greece
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Ioannina
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Greece
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Piraeus
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Italy
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Cagliari
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Italy
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Cinisello Balsamo (MI)
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Italy
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Ferrara
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Italy
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Genova
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Italy
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Messina
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Italy
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Milano
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Italy
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Modena
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Italy
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Napoli
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Italy
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Palermo
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Roma
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Netherlands
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Amsterdam
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Oslo
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Spain
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Aragón
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Spain
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Malmo
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Uppsala
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Switzerland
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Geneva 14
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Switzerland
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Reinach
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United Kingdom
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Bournemouth
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United Kingdom
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Cambridge
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United Kingdom
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Manchester
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United Kingdom
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Peterborough
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United Kingdom
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Stevenage
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Amgen
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02906124
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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MD
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Address
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Amgen
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Phone
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Contact person for public queries
Name
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02906124
Download to PDF