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Study to Evaluate the Safety of Repatha® in Pregnancy

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ClinicalTrials.gov Identifier: NCT02906124
Recruitment Status : Terminated
First Posted : September 19, 2016
Last Update Posted : December 22, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

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

Condition or disease
Hypercholesterolaemia Pregnancy

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

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Study Type : Observational
Actual Enrollment : 4 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy
Actual Study Start Date : January 12, 2017
Actual Primary Completion Date : November 6, 2020
Actual Study Completion Date : November 6, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

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



Primary Outcome Measures :
  1. Any incident of congenital anomaly [ Time Frame: From birth up to 12 months of age ]
    Any incidence of congenital anomaly recorded on the study specific eCRF


Secondary Outcome Measures :
  1. End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth [ Time Frame: From pregnancy diagnosis through to birth ]
    Live birth(s), still birth, spontaneous loss, elective termination, ectopic pregnancy, complication of pregnancy (pre-eclampsia, gestational diabetes)

  2. Status of infant at delivery [ Time Frame: At delivery ]
    Collection of data on gender; gestational age; Apgar score and birth weight

  3. Details of any hospitalisations of infant, documented from delivery to 12 months of age. [ Time Frame: From delivery to 12 months of age ]
    Collection of hospitalisation reason, admission and discharge dates.

  4. Mode of delivery of infant [ Time Frame: At delivery ]
    Collection of delivery mode classified by caesarian section, normal vaginal delivery, operative vaginal delivery and vaginal breech delivery

  5. Growth of infant at 6 months post delivery [ Time Frame: Between birth and 6 months of age ]
    Data on infant growth measured by weight in kilograms.

  6. Details of any chronic medication taken by infant from birth to 12 months of age [ Time Frame: From birth to 12 months of age ]
    Details of any chronic medication prescribed to infant from birth to 12 months of age

  7. Developmental milestones measured at 6 and 12 months of age [ Time Frame: At 6 and 12 months of age of infant ]
    A check of developmental milestones made at 6 and 12 months of age. Details collected where expected milestones were not met.

  8. Details of any complication of delivery [ Time Frame: At delivery ]
    Recording the occurence of any complications of delivery as listed; requirement for blood transfusion, thromboembolism, fetal distress and amniotic fluid abnormality

  9. Growth of infant at 12 months post delivery [ Time Frame: Between birth and 12 months of age ]
    Data on infant growth measured by weight in kilograms.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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®
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906124


Locations
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Australia, New South Wales
Research Site
Camperdown, New South Wales, Australia, 2050
Australia, Victoria
Research Site
Clayton, Victoria, Australia, 3168
Austria
Research Site
Graz, Austria, 8036
Belgium
Research Site
Aalst, Belgium, 9300
Research Site
Edegem, Belgium, 2650
Research Site
La Louvière, Belgium, 7100
Research Site
Leuven, Belgium, 3000
Research Site
Liège, Belgium, 4000
Czechia
Research Site
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
Denmark
Research Site
Aarhus N, Denmark, 8200
Greece
Research Site
Athens, Greece, 11527
Research Site
Heraklion, Greece, 71110
Research Site
Ioannina, Greece, 45500
Research Site
Piraeus, Greece, 18536
Italy
Research Site
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
Netherlands
Research Site
Amsterdam, Netherlands, 1105 AZ
Research Site
Rotterdam, Netherlands, 3015 CE
Norway
Research Site
Oslo, Norway, 0586
Slovakia
Research Site
Bratislava, Slovakia, 831 01
Spain
Research Site
Cordoba, Andalucía, Spain, 14004
Research Site
Malaga, Andalucía, Spain, 29010
Research Site
Zaragoza, Aragón, Spain, 50009
Research Site
Hospitalet de Llobregat, Cataluña, Spain, 08907
Research Site
Reus, Cataluña, Spain, 43204
Sweden
Research Site
Malmo, Sweden, 205 02
Research Site
Uppsala, Sweden, 751 85
Switzerland
Research Site
Geneva 14, Switzerland, 1211
Research Site
Reinach, Switzerland, 4153
United Kingdom
Research Site
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
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen
Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02906124    
Other Study ID Numbers: 20150162
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: December 22, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
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.
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.
URL: https://www.amgen.com/datasharing

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amgen:
hypercholesterolaemia
Lipid lowering therapies
Pregnancy
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases