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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02906124
Ethics application status
Date submitted
1/08/2016
Date registered
19/09/2016

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
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
Timepoint [1] 0 0
From pregnancy diagnosis through to birth
Secondary outcome [2] 0 0
Status of infant at delivery
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.
Timepoint [3] 0 0
From delivery to 12 months of age
Secondary outcome [4] 0 0
Mode of delivery of infant
Timepoint [4] 0 0
At delivery
Secondary outcome [5] 0 0
Growth of infant at 6 months post delivery
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
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
Timepoint [7] 0 0
At 6 and 12 months of age of infant
Secondary outcome [8] 0 0
Details of any complication of delivery
Timepoint [8] 0 0
At delivery
Secondary outcome [9] 0 0
Growth of infant at 12 months post delivery
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
Sex
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
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/11/2020
Sample size
Target
Accrual to date
Final
4
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
Trial website
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
When will data be available (start and end dates)?
Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Available to whom?
Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.amgen.com/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02906124