Evolocumab Pregnancy Exposure Registry

December 15, 2020 updated by: Amgen

Evolocumab Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study

This is a prospective observational registry study to evaluate fetal, infant and childhood outcomes in women exposed to evolocumab during pregnancy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This pregnancy registry will be conducted by University of California Research Center for the Organization of Teratology Information Specialists (OTIS) which is a network of university and health department based telephone information centers serving pregnant women and healthcare providers throughout North America. Participants will be enrolled on an ongoing basis through year 10 of the study and each will be followed from the time they enroll, through the 5-year postnatal follow up period for an overall study period of 15 years. Participants are recruited concurrently from callers to OTIS centers, from healthcare providers and through direct to consumer marketing efforts.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women diagnosed with ASCVD or hypercholesterolemia associated with FH and pregnant women who have been exposed to Evolocumab (Repatha) during pregnancy and who reside in the U.S. or Canada

Description

Inclusion Criteria:

  • For all groups: Qualified subjects will agree to the conditions and requirements of the study including the interview schedule, release of medical records, the physical examination of live born infants, and 5 years of follow-up.
  • For the Specific Evolocumab-Exposed Cohort: Currently pregnant women (maternal report validated by medical records) diagnosed with ASCVD, or hypercholesterolemia associated with FH who have been exposed to evolocumab for any number of days, at any dose, and at any time from the first day of the LMP up to and including the end of pregnancy.
  • For Comparison Group I: Currently pregnant women (maternal report validated by medical records) diagnosed with ASCVD, or hypercholesterolemia associated with FH but who were not exposed to evolocumab during pregnancy or any time within 90 days prior to the first day of the LMP.
  • For Comparison Group II: Currently pregnant women not diagnosed with ASCVD, or hypercholesterolemia associated with FH who have not been exposed to evolocumab during pregnancy or any time within 90 days prior to the first day of the LMP, and who have no exposure to any known human teratogens as determined by the OTIS Research Center
  • For General Evolocumab-Exposed Case Series group: Women with exposure to evolocumab during pregnancy who do not meet the criteria for the Specific Evolocumab-Exposed cohort for reasons including (but not limited to): they do not have ASCVD and/or hypercholesterolemia associated with FH (off-label use), they were exposed to evolocumab but the pregnancy has already completed, they enrolled in the cohort study with a previous pregnancy, or they already have a prenatal diagnosis of a major birth defect

Exclusion Criteria:

For all groups except the General Evolocumab Exposed Case Series Group:

  • Women who first contact the Registry after prenatal diagnosis of a major structural defect
  • Women who were exposed to a different PCSK9 inhibitor during their current pregnancy or at any time within 5 half-lives prior to the first day of the LMP
  • Women who have enrolled in this Registry with a previous pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Specific Evolocumab-Exposed Cohort
Women diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD), or hypercholesterolemia associated with Familial Hypercholesterolemia (FH), who were exposed to Evolocumab (Repatha) during pregnancy
Drug: evolocumab
Pregnant women exposed to evolocumab. Evolocumab is not administered in this non-interventional study.
Other Names:
  • Repatha
Comparison Group I
Women diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD), or hypercholesterolemia associated with Familial Hypercholesterolemia (FH) who were not exposed to Evolocumab during pregnancy
Comparison Group II
A general comparison group of pregnant women who have not been diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD), or hypercholesterolemia associated with Familial Hypercholesterolemia (FH), and who were not exposed to Evolocumab during pregnancy.
General Evolocumab-Exposed Case Series
Women who were exposed to Evolocumab (Repatha) but do not fulfill eligibility criteria for the Specific Evolocumab-Exposed Cohort
Drug: evolocumab
Pregnant women exposed to evolocumab. Evolocumab is not administered in this non-interventional study.
Other Names:
  • Repatha

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of major structural defects
Time Frame: Up to 1 year of age
Rate of major structural defects, defined and classified by the Centers for Disease Control and Prevention (CDC) Metropolitan Atlanta Congenital Defects Program (MACDP) 6 Digit Code Defects List coding manual (CDC, 2007)
Up to 1 year of age

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pregnancy Outcome: Rate of spontaneous abortion
Time Frame: Up to 19 wks post LMP
Rate of spontaneous abortion where spontaneous abortion is defined as non-deliberate fetal death which occurs prior to 19 completed weeks post-last menstrual period (LMP)
Up to 19 wks post LMP
Pregnancy Outcome: Rate of elective abortion
Time Frame: Through 9 month pregnancy period
Rate of elective abortion where elective abortion is defined as deliberate termination of pregnancy at any time in gestation
Through 9 month pregnancy period
Pregnancy Outcome: Rate of stillbirth
Time Frame: At or after 19 completed weeks post LMP
Rate of stillbirth where stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 19 completed weeks post-LMP
At or after 19 completed weeks post LMP
Pregnancy Outcome: Rate of premature delivery
Time Frame: Prior to 37 weeks of gestation
Rate of premature delivery where premature delivery is defined as live birth prior to 37.0 weeks gestation as counted from LMP (or ultrasound adjusted date)
Prior to 37 weeks of gestation
Infant Outcome: Rate of minor structural defects
Time Frame: Between birth and 12 months post natal
Rate of minor structural defects where a minor structural defect is defined as a structural anomaly which has neither cosmetic nor functional significance to the child.
Between birth and 12 months post natal
Infant Outcome: Rate of small for gestational age
Time Frame: At birth
Rate of small for gestational age where small for gestational age is defined as birth size (weight, length, or head circumference) less than/equal to the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants
At birth
Infant Outcome: Rate of postnatal growth deficiency
Time Frame: Up to 1 year of age
Rate of postnatal growth deficiency where postnatal growth deficiency is defined as postnatal size (weight, length, or head circumference) less than/equal to the 10th centile for sex and age using standard pediatric growth curves, and adjusted for postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age.
Up to 1 year of age
Infant Outcome: Rate of postnatal hospitalizations
Time Frame: Through 5 years postnatal
Rate of postnatal hospitalizations as assessed throughout the 5-year postnatal follow-up period.
Through 5 years postnatal
Infant Outcome: Rate of infant reactions to scheduled vaccinations
Time Frame: Through 5 years postnatal
Rate of infant reactions to scheduled vaccinations as assessed throughout the 5-year postnatal follow-up period.
Through 5 years postnatal
Infant Outcome: Infant response to IgG-tetanus antibody
Time Frame: Between 6-12 months of age
Infant response to IgG-tetanus antibody as a biological marker to evaluate humoral immune response via a standardized assay test.
Between 6-12 months of age
Infant Outcome: Adverse neurodevelopment outcomes
Time Frame: Between 16 months to 17 months 30 days of age and between 3.5-5 years of age
Adverse neurodevelopmental outcomes as assessed during 2 periods (between 16 months to 17 months 30 days of age and between 3.5-5 years of age) via standardized tests of performance
Between 16 months to 17 months 30 days of age and between 3.5-5 years of age
Breastfeeding/Lactation Outcome: Proportion of women who breastfed
Time Frame: Through 6 weeks post delivery
Proportion of women who breastfed (at all) in the first 6 weeks after delivery
Through 6 weeks post delivery
Breastfeeding/Lactation Outcome: Proportion who breastfed exclusively
Time Frame: Through the first 2 weeks postnatal
Among women who breastfed (in the first 6 weeks after delivery), the proportion who breastfed exclusively during the first 2 weeks of life
Through the first 2 weeks postnatal
Infant Outcome: Pattern of minor structural defects
Time Frame: Between birth and 12 months postnatal
Pattern of minor structural defects where a minor structural defect is defined as a structural anomaly which has neither cosmetic nor functional significance to the child and a pattern is defined as the same 3 or more minor structural defects in 2 or more children.
Between birth and 12 months postnatal
Infant Outcome: Rate of postnatal serious infections
Time Frame: Through 5 years postnatal
Rate of postnatal serious infections as assessed throughout the 5-year postnatal follow-up period.
Through 5 years postnatal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Organization of Teratology Information Specialists (OTIS) Research Center - tel: 1-866-626-6847 or www.mothertobaby.org

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 22, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 2, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 26, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20150338

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
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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