Study to Evaluate the Safety of Repatha® in Pregnancy

A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy

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

Study Overview

• Status: Terminated
• Conditions: Pregnancy; Hypercholesterolaemia

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

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Research Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Research Site
• Austria
  • Graz, Austria, 8036
    • Research Site
• Belgium
  • Aalst, Belgium, 9300
    • Research Site
  • Edegem, Belgium, 2650
    • Research Site
  • La Louvière, Belgium, 7100
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Liège, Belgium, 4000
    • Research Site
• Czechia
  • Hradec Kralove, Czechia, 500 05
    • Research Site
  • Liberec, Czechia, 460 63
    • Research Site
  • Praha 2, Czechia, 128 08
    • Research Site
  • Uherske Hradiste, Czechia, 686 01
    • Research Site
• Denmark
  • Aarhus N, Denmark, 8200
    • Research Site
• Greece
  • Athens, Greece, 11527
    • Research Site
  • Heraklion, Greece, 71110
    • Research Site
  • Ioannina, Greece, 45500
    • Research Site
  • Piraeus, Greece, 18536
    • Research Site
• Italy
  • Cagliari, Italy, 09134
    • Research Site
  • Cinisello Balsamo (MI), Italy, 20092
    • Research Site
  • Ferrara, Italy, 44124
    • Research Site
  • Genova, Italy, 16132
    • Research Site
  • Messina, Italy, 89125
    • Research Site
  • Milano, Italy, 20122
    • Research Site
  • Milano, Italy, 20162
    • Research Site
  • Modena, Italy, 41126
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Palermo, Italy, 90127
    • Research Site
  • Perugia, Italy, 06129
    • Research Site
  • Pisa, Italy, 56100
    • Research Site
  • Roma, Italy, 00161
    • Research Site
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Research Site
  • Rotterdam, Netherlands, 3015 CE
    • Research Site
• Norway
  • Oslo, Norway, 0586
    • Research Site
• Slovakia
  • Bratislava, Slovakia, 831 01
    • Research Site
• Spain
  • Andalucía
    • Cordoba, Andalucía, Spain, 14004
      • Research Site
    • Malaga, Andalucía, Spain, 29010
      • Research Site
  • Aragón
    • Zaragoza, Aragón, Spain, 50009
      • Research Site
  • Cataluña
    • Hospitalet de Llobregat, Cataluña, Spain, 08907
      • Research Site
    • Reus, Cataluña, Spain, 43204
      • Research Site
• Sweden
  • Malmo, Sweden, 205 02
    • Research Site
  • Uppsala, Sweden, 751 85
    • Research Site
• Switzerland
  • Geneva 14, Switzerland, 1211
    • Research Site
  • Reinach, Switzerland, 4153
    • Research Site
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Research Site
  • Cambridge, United Kingdom, CB2 0QQ
    • Research Site
  • Manchester, United Kingdom, M13 9WL
    • Research Site
  • Peterborough, United Kingdom, PE3 9GZ
    • Research Site
  • Stevenage, United Kingdom, SG1 4AB
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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®

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any incident of congenital anomaly	Any incidence of congenital anomaly recorded on the study specific eCRF	From birth up to 12 months of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From pregnancy diagnosis through to birth
Status of infant at delivery	Collection of data on gender; gestational age; Apgar score and birth weight	At delivery
Details of any hospitalisations of infant, documented from delivery to 12 months of age.	Collection of hospitalisation reason, admission and discharge dates.	From delivery to 12 months of age
Mode of delivery of infant	Collection of delivery mode classified by caesarian section, normal vaginal delivery, operative vaginal delivery and vaginal breech delivery	At delivery
Growth of infant at 6 months post delivery	Data on infant growth measured by weight in kilograms.	Between birth and 6 months of age
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	From birth to 12 months of age
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.	At 6 and 12 months of age of infant
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	At delivery
Growth of infant at 12 months post delivery	Data on infant growth measured by weight in kilograms.	Between birth and 12 months of age

Collaborators and Investigators

• Sponsor: Amgen

Publications and helpful links

Helpful Links

• AmgenTrials clinical trials website

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2017
• Primary Completion (Actual): November 6, 2020
• Study Completion (Actual): November 6, 2020

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: September 14, 2016
• First Posted (Estimate): September 19, 2016

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Pregnancy; hypercholesterolaemia; Lipid lowering therapies
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: 20150162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: No