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Trial record 51 of 96 for:    Recruiting, Not yet recruiting, Available Studies | "Cholesterol"

Evolocumab Pregnancy Exposure Registry

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ClinicalTrials.gov Identifier: NCT02957604
Recruitment Status : Recruiting
First Posted : November 8, 2016
Last Update Posted : October 17, 2019
Sponsor:
Collaborator:
Organization of Teratology Information Specialists (OTIS) Research Center - tel: 1-866-626-6847 or www.mothertobaby.org
Information provided by (Responsible Party):
Amgen

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

Condition or disease Intervention/treatment
Hypercholesterolemia; ASCVD; Pregnancy Drug: evolocumab

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 375 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Evolocumab Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
Actual Study Start Date : December 22, 2016
Estimated Primary Completion Date : April 28, 2032
Estimated Study Completion Date : April 28, 2032

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Group/Cohort Intervention/treatment
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 Name: 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 Name: Repatha




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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)

  5. 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.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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

  12. 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

  13. 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

  14. 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.

  15. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Criteria

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

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): NCT02957604


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
Research Site Recruiting
La Jolla, California, United States, 92093
Sponsors and Collaborators
Amgen
Organization of Teratology Information Specialists (OTIS) Research Center - tel: 1-866-626-6847 or www.mothertobaby.org
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02957604     History of Changes
Other Study ID Numbers: 20150338
First Posted: November 8, 2016    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
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
Keywords provided by Amgen:
Pregnancy; Cardiovascular Diseases; High serum cholesterol; FH; ASCVD
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Evolocumab
Antibodies, Monoclonal
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Immunologic Factors
Physiological Effects of Drugs