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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02906124




Registration number
NCT02906124
Ethics application status
Date submitted
1/08/2016
Date registered
19/09/2016
Date last updated
18/06/2020

Titles & IDs
Public title
Study to Evaluate the Safety of Repatha® in Pregnancy
Scientific title
A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy
Secondary ID [1] 0 0
20150162
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolaemia 0 0
Pregnancy 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Any incident of congenital anomaly - Any incidence of congenital anomaly recorded on the study specific eCRF
Timepoint [1] 0 0
From birth up to 12 months of age
Secondary outcome [1] 0 0
End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth - Live birth(s), still birth, spontaneous loss, elective termination, ectopic pregnancy, complication of pregnancy (pre-eclampsia, gestational diabetes)
Timepoint [1] 0 0
From pregnancy diagnosis through to birth
Secondary outcome [2] 0 0
Status of infant at delivery - Collection of data on gender; gestational age; Apgar score and birth weight
Timepoint [2] 0 0
At delivery
Secondary outcome [3] 0 0
Details of any hospitalisations of infant, documented from delivery to 12 months of age. - Collection of hospitalisation reason, admission and discharge dates.
Timepoint [3] 0 0
From delivery to 12 months of age
Secondary outcome [4] 0 0
Mode of delivery of infant - Collection of delivery mode classified by caesarian section, normal vaginal delivery, operative vaginal delivery and vaginal breech delivery
Timepoint [4] 0 0
At delivery
Secondary outcome [5] 0 0
Growth of infant at 6 months post delivery - Data on infant growth measured by weight in kilograms.
Timepoint [5] 0 0
Between birth and 6 months of age
Secondary outcome [6] 0 0
Details of any chronic medication taken by infant from birth to 12 months of age - Details of any chronic medication prescribed to infant from birth to 12 months of age
Timepoint [6] 0 0
From birth to 12 months of age
Secondary outcome [7] 0 0
Developmental milestones measured at 6 and 12 months of age - A check of developmental milestones made at 6 and 12 months of age. Details collected where expected milestones were not met.
Timepoint [7] 0 0
At 6 and 12 months of age of infant
Secondary outcome [8] 0 0
Details of any complication of delivery - Recording the occurence of any complications of delivery as listed; requirement for blood transfusion, thromboembolism, fetal distress and amniotic fluid abnormality
Timepoint [8] 0 0
At delivery
Secondary outcome [9] 0 0
Growth of infant at 12 months post delivery - Data on infant growth measured by weight in kilograms.
Timepoint [9] 0 0
Between birth and 12 months of age

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
Minimum age
No limit
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
There are no exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Belgium
State/province [2] 0 0
Aalst
Country [3] 0 0
Belgium
State/province [3] 0 0
Edegem
Country [4] 0 0
Belgium
State/province [4] 0 0
La Louvière
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Belgium
State/province [6] 0 0
Liège
Country [7] 0 0
Czechia
State/province [7] 0 0
Hradec Kralove
Country [8] 0 0
Czechia
State/province [8] 0 0
Liberec
Country [9] 0 0
Czechia
State/province [9] 0 0
Praha 2
Country [10] 0 0
Czechia
State/province [10] 0 0
Uherske Hradiste
Country [11] 0 0
Denmark
State/province [11] 0 0
Aarhus N
Country [12] 0 0
Greece
State/province [12] 0 0
Athens
Country [13] 0 0
Greece
State/province [13] 0 0
Heraklion
Country [14] 0 0
Greece
State/province [14] 0 0
Ioannina
Country [15] 0 0
Greece
State/province [15] 0 0
Piraeus
Country [16] 0 0
Italy
State/province [16] 0 0
Cagliari
Country [17] 0 0
Italy
State/province [17] 0 0
Cinisello Balsamo (MI)
Country [18] 0 0
Italy
State/province [18] 0 0
Ferrara
Country [19] 0 0
Italy
State/province [19] 0 0
Genova
Country [20] 0 0
Italy
State/province [20] 0 0
Messina
Country [21] 0 0
Italy
State/province [21] 0 0
Milano
Country [22] 0 0
Italy
State/province [22] 0 0
Modena
Country [23] 0 0
Italy
State/province [23] 0 0
Napoli
Country [24] 0 0
Italy
State/province [24] 0 0
Palermo
Country [25] 0 0
Italy
State/province [25] 0 0
Perugia
Country [26] 0 0
Italy
State/province [26] 0 0
Pisa
Country [27] 0 0
Italy
State/province [27] 0 0
Roma
Country [28] 0 0
Netherlands
State/province [28] 0 0
Amsterdam
Country [29] 0 0
Netherlands
State/province [29] 0 0
Rotterdam
Country [30] 0 0
Norway
State/province [30] 0 0
Oslo
Country [31] 0 0
Slovakia
State/province [31] 0 0
Bratislava
Country [32] 0 0
Spain
State/province [32] 0 0
Andalucía
Country [33] 0 0
Spain
State/province [33] 0 0
Aragón
Country [34] 0 0
Spain
State/province [34] 0 0
Cataluña
Country [35] 0 0
Sweden
State/province [35] 0 0
Malmo
Country [36] 0 0
Sweden
State/province [36] 0 0
Uppsala
Country [37] 0 0
Switzerland
State/province [37] 0 0
Geneva 14
Country [38] 0 0
Switzerland
State/province [38] 0 0
Reinach
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Bournemouth
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Cambridge
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Manchester
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Peterborough
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Stevenage

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/show/NCT02906124
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02906124