HypercholesterolemiaNCT03379558
Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
An observational study of Hypercholesterolemia, run by Regeneron Pharmaceuticals at 1 site in United States.
Trial summary
Primary Objective: To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent® (alirocumab) during pregnancy when used to treat hypercholesterolemia and to compare that… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- ALIROCUMAB SAR236553 (REGN727)
- Type of treatment
- Injection or infusion
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2017to 4 Sep 2020
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Pregnant women who enroll in the study will participate for the duration of that pregnancy.Those who deliver at least one live born infant and the infants will participate for 5 years after delivery of that infant.
Who may be able to join
- Cohort 1: Alirocumab-Exposed:
- Currently pregnant - Diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia - Exposed to alirocumab for any number of days, at any dose, and at any time from the first day of the last menstrual period up to and including the end of pregnancy - Agree to the conditions and requirements of the study and provide informed consent.
- Cohort 2: Disease-Matched Comparison:
- Currently pregnant - Diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia - Unexposed to alirocumab or any biologic medication during pregnancy or any time within 10 weeks prior to the first day of the last menstrual period - Agree to the conditions and requirements of the study and provide informed consent.
- Cohort 3: Non-Diseased Comparison:
- Currently pregnant - Not diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia - Unexposed to alirocumab or any biologic any time in pregnancy or within 10 weeks prior to the first day of the last menstrual period - Unexposed to any known human teratogens as determined by the Organization of Teratology Information Specialists Research Center - Agree to the conditions and requirements of the study and provide informed consent.
Who cannot join
- Cohort 1: Alirocumab-Exposed:
- First contact the Registry after prenatal diagnosis of a major structural birth defect - Enrollment in this pregnancy registry study with a previous pregnancy - Pregnancy outcome is reported retrospectively.
- Cohort 2: Disease-Matched Comparison:
- First contact the Registry after prenatal diagnosis of a major structural birth defect - Exposure to any alirocumab or other biologic medication during pregnancy or within 10 weeks prior to the first day of the last menstrual period - Enrollment in this pregnancy registry study with a previous pregnancy - Pregnancy outcome is reported retrospectively.
- Cohort 3: Non-Diseased Comparison:
- First contact the Registry after prenatal diagnosis of a major structural birth defect - Exposure to alirocumab or other biologic medication during pregnancy or within 10 weeks prior to the first day of the last menstrual period - Exposure to a known human teratogen as determined by the Organization of Teratology Information Specialists Research Center - Enrollment in this pregnancy registry study with a previous pregnancy - Pregnancy outcome is reported retrospectively.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Investigational site UNITED STATES
San Diego, California, 00000
About this study
Primary Objective:
To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent® (alirocumab) during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and unexposed non-diseased comparison pregnancies.
Read more
Secondary Objectives:
- Secondary objectives are to estimate the rates of the outcomes in pregnancies/infants of mothers with atherosclerotic cardiovascular disease and/or familial hypercholesterolemia exposed to alirocumab during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and non-diseased comparison pregnancies, and secondarily to compare the rates of these outcomes in the unexposed disease-matched pregnancies to the rates in the unexposed non-diseased comparison pregnancies.
- Safety and tolerability of alirocumab.
- Conditions
- Hypercholesterolemia
- Being tested
- ALIROCUMAB SAR236553 (REGN727)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIROCUMAB SAR236553 (REGN727)Drug
Also called Praluent®
Pharmaceutical form:as per routine practice Route of administration: subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 : alirocumab exposed | Pregnant women diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia and exposed to alirocumab during the current pregnancy. Receives: Drug: ALIROCUMAB SAR236553 (REGN727) | |
| Cohort 2 : disease matched comparison | Pregnant women diagnosed of primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia and unexposed to alirocumab during the current pregnancy. | |
| Cohort 3 : non disease comparison | Healthy pregnant women who do not have a known diagnosis of primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia and have no known exposure to a known human teratogen. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of major structural birth defects
Overall combined rate of major structural birth defects in infants born to females with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent (alirocumab)
Measured: Up to 1 year of age of the infant
Secondary outcomes (13)
Pregnancy outcome: Spontaneous abortion
Rate of spontaneous abortion
Measured: Date of conception to 20 weeks gestation
Pregnancy outcome: Elective abortion
Rate of elective abortion
Measured: Date of conception to 20 weeks gestation
Pregnancy outcome: Still birth
Rate of still birth
Measured: At birth
Pregnancy outcome: Preterm delivery
Rate of preterm delivery
Measured: Live birth prior to 37 weeks gestation
Infant outcome: Pattern of minor structural birth defects
Specific pattern of 3 or more minor structural defects in live born infants receiving the exam
Measured: Up to 1 year of age of the infant
Infant outcome: Small for gestational age
Proportion of infants who are small for gestational age on weight, length, or head circumference
Measured: At birth
Infant outcome: Postnatal growth deficiency
Proportion of infants less than or equal to the 10th percentile for sex and age on weight, length, or head circumference at 1 year postnatal evaluation
Measured: Up to 1 year of age of the infant
Infant outcome: serious infections or hospitalizations, adverse reactions to childhood vaccinations
Proportion of infants who experienced serious infections or hospitalizations, and adverse reactions to childhood vaccinations
Measured: Up to 5 years of age of the child
Infant outcome: adequacy of immune response
Proportion of infants who has adequate immune response as measured by IgG-Tetanus antibody
Measured: Up to 5 years of age of the child
Infant outcome: adverse neurodevelopment
Proportion of infants who experienced adverse neurodevelopment
Measured: Up to 5 years of age of the child
Breastfeeding/Lactation outcome
Proportion of patients breastfeeding in the first 6 weeks after delivery
Measured: Up to 6 weeks of age of the infant
Breastfeeding/Lactation outcome
Proportion of patients breastfeeding exclusively for more than 2 weeks
Measured: Up to 2 years of age of the child
Adverse events
Proportion of patients who experienced adverse events (AEs), AEs of special interest, and serious AEs
Measured: Up to 5 years follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start19 Dec 2017
- Primary completion4 Sep 2020
- Study completion4 Sep 2020
Why it stopped: (due to change in the post-marketing requirement to assess alirocumab during pregnancy)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379558
- Sponsor's protocol ID
- OBS14703
- Other IDs
- U1111-1195-6468
- Status last verified
- Nov 2020
- First submitted
- 15 Dec 2017
- Last updated
- 23 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Praluent® (Alirocumab) Pregnancy Exposure Registry: An OTIS Pregnancy Surveillance Study
- ClinicalTrials.gov ID
- NCT03379558
- Acronym / sponsor ID
- OBS14703
- Conditions
- Hypercholesterolemia
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: (due to change in the post-marketing requirement to assess alirocumab during pregnancy)
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Collaborators
- Sanofi
- Study start
- 19 Dec 2017 (actual)
- Primary completion
- 4 Sep 2020 (actual)
- Study completion
- 4 Sep 2020 (actual)
- First posted
- 20 Dec 2017 (actual)
- 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.
Primary Objective:
To estimate the overall combined rate of major structural birth defects in infants of mothers with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent® (alirocumab) during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and unexposed non-diseased comparison pregnancies.
Secondary Objectives:
- Secondary objectives are to estimate the rates of the outcomes in pregnancies/infants of mothers with atherosclerotic cardiovascular disease and/or familial hypercholesterolemia exposed to alirocumab during pregnancy when used to treat hypercholesterolemia and to compare that rate to unexposed disease-matched and non-diseased comparison pregnancies, and secondarily to compare the rates of these outcomes in the unexposed disease-matched pregnancies to the rates in the unexposed non-diseased comparison pregnancies.
- Safety and tolerability of alirocumab.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 : alirocumab exposed | – | Drug: ALIROCUMAB SAR236553 (REGN727)Pregnant women diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia and exposed to alirocumab during the current pregnancy. |
| Cohort 2 : disease matched comparison | – | –Pregnant women diagnosed of primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia and unexposed to alirocumab during the current pregnancy. |
| Cohort 3 : non disease comparison | – | –Healthy pregnant women who do not have a known diagnosis of primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia and have no known exposure to a known human teratogen. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pregnant women who enroll in the study will participate for the duration of that pregnancy.Those who deliver at least one live born infant and the infants will participate for 5 years after delivery of that infant.
Key inclusion criteria (6 listed)
- Currently pregnant - Diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia - Exposed to alirocumab for any number of days, at any dose, and at any time from the first day of the last menstrual period up to and including the end of pregnancy - Agree to the conditions and requirements of the study and provide informed consent.
- Currently pregnant - Diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia - Unexposed to alirocumab or any biologic medication during pregnancy or any time within 10 weeks prior to the first day of the last menstrual period - Agree to the conditions and requirements of the study and provide informed consent.
- Currently pregnant - Not diagnosed with primary hypercholesterolemia and atherosclerotic cardiovascular disease, or primary hypercholesterolemia associated with familial hypercholesterolemia - Unexposed to alirocumab or any biologic any time in pregnancy or within 10 weeks prior to the first day of the last menstrual period - Unexposed to any known human teratogens as determined by the Organization of Teratology Information Specialists Research Center - Agree to the conditions and requirements of the study and provide informed consent.
Key exclusion criteria (7 listed)
- First contact the Registry after prenatal diagnosis of a major structural birth defect - Enrollment in this pregnancy registry study with a previous pregnancy - Pregnancy outcome is reported retrospectively.
- First contact the Registry after prenatal diagnosis of a major structural birth defect - Exposure to any alirocumab or other biologic medication during pregnancy or within 10 weeks prior to the first day of the last menstrual period - Enrollment in this pregnancy registry study with a previous pregnancy - Pregnancy outcome is reported retrospectively.
- First contact the Registry after prenatal diagnosis of a major structural birth defect - Exposure to alirocumab or other biologic medication during pregnancy or within 10 weeks prior to the first day of the last menstrual period - Exposure to a known human teratogen as determined by the Organization of Teratology Information Specialists Research Center - Enrollment in this pregnancy registry study with a previous pregnancy - Pregnancy outcome is reported retrospectively.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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 |
|---|---|---|
| ALIROCUMAB SAR236553 (REGN727)Also: Praluent®Pharmaceutical form:as per routine practice Route of administration: subcutaneous | Drug | Cohort 1 : alirocumab exposed |
Primary outcome
Rate of major structural birth defects
Time frame: Up to 1 year of age of the infant
Overall combined rate of major structural birth defects in infants born to females with atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) exposed to Praluent (alirocumab)
13 secondary outcomes
Pregnancy outcome: Spontaneous abortion
Time frame: Date of conception to 20 weeks gestation
Pregnancy outcome: Elective abortion
Time frame: Date of conception to 20 weeks gestation
Pregnancy outcome: Still birth
Time frame: At birth
Pregnancy outcome: Preterm delivery
Time frame: Live birth prior to 37 weeks gestation
Infant outcome: Pattern of minor structural birth defects
Time frame: Up to 1 year of age of the infant
Infant outcome: Small for gestational age
Time frame: At birth
Infant outcome: Postnatal growth deficiency
Time frame: Up to 1 year of age of the infant
Infant outcome: serious infections or hospitalizations, adverse reactions to childhood vaccinations
Time frame: Up to 5 years of age of the child
Infant outcome: adequacy of immune response
Time frame: Up to 5 years of age of the child
Infant outcome: adverse neurodevelopment
Time frame: Up to 5 years of age of the child
Breastfeeding/Lactation outcome
Time frame: Up to 6 weeks of age of the infant
Breastfeeding/Lactation outcome
Time frame: Up to 2 years of age of the child
Adverse events
Time frame: Up to 5 years follow-up period
Results and safety
The study was stopped early (reason given: (due to change in the post-marketing requirement to assess alirocumab during pregnancy)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Clinical Sciences & Operations study director
Sanofi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolemia, run by Regeneron Pharmaceuticals at 1 site in United States.
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 6 inclusion and 7 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 23 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (reason given: (due to change in the post-marketing requirement to assess alirocumab during pregnancy)). 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 birth defects (time frame: Up to 1 year of age of the infant). 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 23 Nov 2020.