Hypercholesterolemia; ASCVD; PregnancyNCT02957604
Evolocumab Pregnancy Exposure Registry
An observational study of Hypercholesterolemia; ASCVD; Pregnancy, run by Amgen.
Trial summary
This is a prospective observational registry study to evaluate fetal, infant and childhood outcomes in women exposed to evolocumab during pregnancy Read more about this study
- Who is it for?
- Ages 1 year to 100 years, women only
- Conditions the study is for
- Hypercholesterolemia; ASCVD; Pregnancy
- What is being tested?
- evolocumab
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2016to 2 Sep 2020
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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
Read the 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.
- Conditions
- Hypercholesterolemia; ASCVD; Pregnancy
- Being tested
- evolocumab
- Keywords
- Pregnancy; Cardiovascular Diseases; High serum cholesterol; FH; ASCVD
- Medical subject headings
- Hypercholesterolemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
evolocumabDrug
Also called Repatha
Pregnant women exposed to evolocumab. Evolocumab is not administered in this non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: evolocumab | |
| 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 Receives: Drug: evolocumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major structural defects
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)
Measured: Up to 1 year of age
Secondary outcomes (15)
Pregnancy Outcome: Rate of spontaneous abortion
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)
Measured: Up to 19 wks post LMP
Pregnancy Outcome: Rate of elective abortion
Rate of elective abortion where elective abortion is defined as deliberate termination of pregnancy at any time in gestation
Measured: Through 9 month pregnancy period
Pregnancy Outcome: Rate of stillbirth
Rate of stillbirth where stillbirth is defined as non-deliberate fetal death anytime in gestation at or after 19 completed weeks post-LMP
Measured: At or after 19 completed weeks post LMP
Pregnancy Outcome: Rate of premature delivery
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)
Measured: Prior to 37 weeks of gestation
Infant Outcome: Rate of minor structural defects
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.
Measured: Between birth and 12 months post natal
Infant Outcome: Rate of small for gestational age
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
Measured: At birth
Infant Outcome: Rate of postnatal growth deficiency
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.
Measured: Up to 1 year of age
Infant Outcome: Rate of postnatal hospitalizations
Rate of postnatal hospitalizations as assessed throughout the 5-year postnatal follow-up period.
Measured: Through 5 years postnatal
Infant Outcome: Rate of infant reactions to scheduled vaccinations
Rate of infant reactions to scheduled vaccinations as assessed throughout the 5-year postnatal follow-up period.
Measured: Through 5 years postnatal
Infant Outcome: Infant response to IgG-tetanus antibody
Infant response to IgG-tetanus antibody as a biological marker to evaluate humoral immune response via a standardized assay test.
Measured: Between 6-12 months of age
Infant Outcome: Adverse neurodevelopment outcomes
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
Measured: 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
Proportion of women who breastfed (at all) in the first 6 weeks after delivery
Measured: Through 6 weeks post delivery
Breastfeeding/Lactation Outcome: Proportion who breastfed exclusively
Among women who breastfed (in the first 6 weeks after delivery), the proportion who breastfed exclusively during the first 2 weeks of life
Measured: Through the first 2 weeks postnatal
Infant Outcome: Pattern of minor structural defects
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.
Measured: Between birth and 12 months postnatal
Infant Outcome: Rate of postnatal serious infections
Rate of postnatal serious infections as assessed throughout the 5-year postnatal follow-up period.
Measured: Through 5 years postnatal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start22 Dec 2016
- Primary completion2 Sep 2020
- Study completion2 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercholesterolemia; ASCVD; PregnancyStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Organization of Teratology Information Specialists (OTIS) Research Center - tel: 1-866-626-6847 or www.mothertobaby.org
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02957604
- Sponsor's protocol ID
- 20150338
- Status last verified
- Dec 2020
- First submitted
- 26 Oct 2016
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolocumab Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
- ClinicalTrials.gov ID
- NCT02957604
- Acronym / sponsor ID
- 20150338
- Conditions
- Hypercholesterolemia; ASCVD; Pregnancy
- Keywords
- Pregnancy; Cardiovascular Diseases; High serum cholesterol; FH; ASCVD
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 140 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Collaborators
- Organization of Teratology Information Specialists (OTIS) Research Center - tel: 1-866-626-6847 or www.mothertobaby.org
- Study start
- 22 Dec 2016 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 2 Sep 2020 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective observational registry study to evaluate fetal, infant and childhood outcomes in women exposed to evolocumab during pregnancy
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Specific Evolocumab-Exposed Cohort | – | Drug: evolocumabWomen diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD), or hypercholesterolemia associated with Familial Hypercholesterolemia (FH), who were exposed to Evolocumab (Repatha) during pregnancy |
| 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 | – | Drug: evolocumabWomen who were exposed to Evolocumab (Repatha) but do not fulfill eligibility criteria for the Specific Evolocumab-Exposed Cohort |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| evolocumabAlso: RepathaPregnant women exposed to evolocumab. Evolocumab is not administered in this non-interventional study. | Drug | General Evolocumab-Exposed Case Series, Specific Evolocumab-Exposed Cohort |
Primary outcome
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)
15 secondary outcomes
Pregnancy Outcome: Rate of spontaneous abortion
Time frame: Up to 19 wks post LMP
Pregnancy Outcome: Rate of elective abortion
Time frame: Through 9 month pregnancy period
Pregnancy Outcome: Rate of stillbirth
Time frame: At or after 19 completed weeks post LMP
Pregnancy Outcome: Rate of premature delivery
Time frame: Prior to 37 weeks of gestation
Infant Outcome: Rate of minor structural defects
Time frame: Between birth and 12 months post natal
Infant Outcome: Rate of small for gestational age
Time frame: At birth
Infant Outcome: Rate of postnatal growth deficiency
Time frame: Up to 1 year of age
Infant Outcome: Rate of postnatal hospitalizations
Time frame: Through 5 years postnatal
Infant Outcome: Rate of infant reactions to scheduled vaccinations
Time frame: Through 5 years postnatal
Infant Outcome: Infant response to IgG-tetanus antibody
Time frame: 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
Breastfeeding/Lactation Outcome: Proportion of women who breastfed
Time frame: Through 6 weeks post delivery
Breastfeeding/Lactation Outcome: Proportion who breastfed exclusively
Time frame: Through the first 2 weeks postnatal
Infant Outcome: Pattern of minor structural defects
Time frame: Between birth and 12 months postnatal
Infant Outcome: Rate of postnatal serious infections
Time frame: Through 5 years postnatal
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia; ASCVD; Pregnancy, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of major structural defects (time frame: Up to 1 year of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.