HypercholesterolaemiaNCT02906124
Study to Evaluate the Safety of Repatha® in Pregnancy
An observational study of Hypercholesterolaemia and Pregnancy, run by Amgen at 48 sites in 14 countries.
Trial 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 Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hypercholesterolaemia, Pregnancy
- How many people
- 4 participants
- Where
- 48 sitesin 14 countries
- Study dates
- 12 Jan 2017to 6 Nov 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Sites in Europe, South Africa and Australia where pregnant familial hypercholesterolaemia (FH) Patients are treated with and without Repatha®
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria
Trial locations and contacts
48 sites in 14 countries.
48 sites in 14 countries
Italy13 sites
Research Site
Cagliari, 09134
Research Site
Cinisello Balsamo (MI), 20092
Research Site
Ferrara, 44124
Research Site
Genova, 16132
Research Site
Messina, 89125
Research Site
Milan, 20122
Research Site
Milan, 20162
Research Site
Modena, 41126
Research Site
Naples, 80131
Research Site
Palermo, 90127
Research Site
Perugia, 06129
Research Site
Pisa, 56100
Research Site
Roma, 00161
Belgium5 sites
Research Site
Aalst, 9300
Research Site
Edegem, 2650
Research Site
La Louvière, 7100
Research Site
Leuven, 3000
Research Site
Liège, 4000
Spain5 sites
Research Site
Córdoba, Andalusia, 14004
Research Site
L'Hospitalet de Llobregat, Catalonia, 08907
Research Site
Málaga, Andalusia, 29010
Research Site
Reus, Catalonia, 43204
Research Site
Zaragoza, Aragon, 50009
United Kingdom5 sites
Research Site
Bournemouth, BH7 7DW
Research Site
Cambridge, CB2 0QQ
Research Site
Manchester, M13 9WL
Research Site
Peterborough, PE3 9GZ
Research Site
Stevenage, SG1 4AB
Czechia4 sites
Research Site
Hradec Králové, 500 05
Research Site
Liberec, 460 63
Research Site
Prague, 128 08
Research Site
Uherské Hradiště, 686 01
Greece4 sites
Research Site
Athens, 11527
Research Site
Heraklion, 71110
Research Site
Ioannina, 45500
Research Site
Piraeus, 18536
Australia2 sites
Research Site
Camperdown, New South Wales, 2050
Research Site
Clayton, Victoria, 3168
Netherlands2 sites
Research Site
Amsterdam, 1105 AZ
Research Site
Rotterdam, 3015 CE
About this study
Official title: A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy
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
Read the detailed description
Women diagnosed with familial hypercholesterolaemia (FH), treated at centres in Europe, South Africa and Australia, with pregnancy confirmed during the study observation period and who provide informed consent to participate in the study.
Exposed subjects are women who received Repatha® during pregnancy and/or breastfeeding; unexposed subjects are women who have not received Repatha® during pregnancy and/or breast-feeding. In infants, exposure may occur in utero and/or via breast milk, within 15 weeks following the date of Repatha® dosing in the mother
- Conditions
- Hypercholesterolaemia, Pregnancy
- Keywords
- hypercholesterolaemia, Lipid lowering therapies, Pregnancy
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any incident of congenital anomaly
Any incidence of congenital anomaly recorded on the study specific eCRF
Measured: 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
Live birth(s), still birth, spontaneous loss, elective termination, ectopic pregnancy, complication of pregnancy (pre-eclampsia, gestational diabetes)
Measured: From pregnancy diagnosis through to birth
Status of infant at delivery
Collection of data on gender; gestational age; Apgar score and birth weight
Measured: At delivery
Details of any hospitalisations of infant, documented from delivery to 12 months of age.
Collection of hospitalisation reason, admission and discharge dates.
Measured: From delivery to 12 months of age
Mode of delivery of infant
Collection of delivery mode classified by caesarian section, normal vaginal delivery, operative vaginal delivery and vaginal breech delivery
Measured: At delivery
Growth of infant at 6 months post delivery
Data on infant growth measured by weight in kilograms.
Measured: Between birth and 6 months of age
Details of any chronic medication taken by infant from birth to 12 months of age
Details of any chronic medication prescribed to infant from birth to 12 months of age
Measured: From birth to 12 months of age
Developmental milestones measured at 6 and 12 months of age
A check of developmental milestones made at 6 and 12 months of age. Details collected where expected milestones were not met.
Measured: At 6 and 12 months of age of infant
Details of any complication of delivery
Recording the occurence of any complications of delivery as listed; requirement for blood transfusion, thromboembolism, fetal distress and amniotic fluid abnormality
Measured: At delivery
Growth of infant at 12 months post delivery
Data on infant growth measured by weight in kilograms.
Measured: Between birth and 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start12 Jan 2017
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolaemiaStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906124
- Sponsor's protocol ID
- 20150162
- Status last verified
- Dec 2020
- First submitted
- 1 Aug 2016
- Last updated
- 22 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- 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 22 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy
- ClinicalTrials.gov ID
- NCT02906124
- Acronym / sponsor ID
- 20150162
- Conditions
- Hypercholesterolaemia, Pregnancy
- Keywords
- hypercholesterolaemia, Lipid lowering therapies, Pregnancy
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2017 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 19 Sep 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.
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
Detailed description
Women diagnosed with familial hypercholesterolaemia (FH), treated at centres in Europe, South Africa and Australia, with pregnancy confirmed during the study observation period and who provide informed consent to participate in the study.
Exposed subjects are women who received Repatha® during pregnancy and/or breastfeeding; unexposed subjects are women who have not received Repatha® during pregnancy and/or breast-feeding. In infants, exposure may occur in utero and/or via breast milk, within 15 weeks following the date of Repatha® dosing in the mother
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sites in Europe, South Africa and Australia where pregnant familial hypercholesterolaemia (FH) Patients are treated with and without Repatha®
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Any incident of congenital anomaly
Time frame: From birth up to 12 months of age
Any incidence of congenital anomaly recorded on the study specific eCRF
9 secondary outcomes
End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth
Time frame: From pregnancy diagnosis through to birth
Status of infant at delivery
Time frame: At delivery
Details of any hospitalisations of infant, documented from delivery to 12 months of age.
Time frame: From delivery to 12 months of age
Mode of delivery of infant
Time frame: At delivery
Growth of infant at 6 months post delivery
Time frame: Between birth and 6 months of age
Details of any chronic medication taken by infant from birth to 12 months of age
Time frame: From birth to 12 months of age
Developmental milestones measured at 6 and 12 months of age
Time frame: At 6 and 12 months of age of infant
Details of any complication of delivery
Time frame: At delivery
Growth of infant at 12 months post delivery
Time frame: Between birth and 12 months of age
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 22 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
48 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypercholesterolaemia and Pregnancy, run by Amgen at 48 sites in 14 countries.
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 1 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 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Italy, Belgium, Spain, United Kingdom, Czechia and 9 more countries. 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. 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?
Any incident of congenital anomaly (time frame: From birth up to 12 months 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 22 Dec 2020.