Study to Evaluate the Safety of Repatha® in Pregnancy

NCT02906124 | Terminated

• 1 other identifier: 20150162
• Study Type: observational
• Target: 4
• Locations: 13 countries
• Sites: 47

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

Conditions

Hypercholesterolaemia; Pregnancy

Keywords

hypercholesterolaemia; Lipid lowering therapies; Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth

  From pregnancy diagnosis through to birth

• Status of infant at delivery

  At delivery

• Details of any hospitalisations of infant, documented from delivery to 12 months of age.

  From delivery to 12 months of age

• Mode of delivery of infant

  At delivery

• Growth of infant at 6 months post delivery

  Between birth and 6 months of age

Study Arms (2)

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

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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®

You may qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (48)

Research Site

Camperdown, New South Wales, 2050, Australia

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Clayton, Victoria, 3168, Australia

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Graz, 8036, Austria

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Aalst, 9300, Belgium

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Edegem, 2650, Belgium

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La Louvière, 7100, Belgium

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Leuven, 3000, Belgium

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Liège, 4000, Belgium

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Hradec Králové, 500 05, Czechia

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Liberec, 460 63, Czechia

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Prague, 128 08, Czechia

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Uherské Hradiště, 686 01, Czechia

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Aarhus N, 8200, Denmark

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Athens, 11527, Greece

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Heraklion, 71110, Greece

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Ioannina, 45500, Greece

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Piraeus, 18536, Greece

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Cagliari, 09134, Italy

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Cinisello Balsamo (MI), 20092, Italy

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Ferrara, 44124, Italy

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Genova, 16132, Italy

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Messina, 89125, Italy

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Milan, 20122, Italy

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Milan, 20162, Italy

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Modena, 41126, Italy

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Napoli, 80131, Italy

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Palermo, 90127, Italy

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Perugia, 06129, Italy

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Pisa, 56100, Italy

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Roma, 00161, Italy

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Amsterdam, 1105 AZ, Netherlands

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Rotterdam, 3015 CE, Netherlands

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Oslo, 0586, Norway

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Bratislava, 831 01, Slovakia

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Córdoba, Andalusia, 14004, Spain

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Málaga, Andalusia, 29010, Spain

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Zaragoza, Aragon, 50009, Spain

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L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Reus, Catalonia, 43204, Spain

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Malmo, 205 02, Sweden

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Uppsala, 751 85, Sweden

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Geneva, 1211, Switzerland

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Reinach, 4153, Switzerland

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Bournemouth, BH7 7DW, United Kingdom

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Cambridge, CB2 0QQ, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Peterborough, PE3 9GZ, United Kingdom

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Stevenage, SG1 4AB, United Kingdom

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Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: September 19, 2016
• Study Start: January 12, 2017
• Primary Completion: November 6, 2020
• Study Completion: November 6, 2020
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

AU (2); SE (2); NO (1); SL (1); CH (2); GB (5); GR (4); IT (13); BE (5); CZ (4); DK (1); NL (2); ES (5)