Clincosm LogoSign in Get a demo

Study to Evaluate the Safety of Repatha® in Pregnancy

Sponsor
Amgen (Industry)
Overall Status
Terminated
CT.gov ID
NCT02906124
Collaborator
(none)
4
Enrollment
48
Locations
45.8
Actual Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Actual Enrollment :
    4 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy
    Actual Study Start Date :
    Jan 12, 2017
    Actual Primary Completion Date :
    Nov 6, 2020
    Actual Study Completion Date :
    Nov 6, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Any incident of congenital anomaly [From birth up to 12 months of age]

      Any incidence of congenital anomaly recorded on the study specific eCRF

    Secondary Outcome Measures

    1. End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth [From pregnancy diagnosis through to birth]

      Live birth(s), still birth, spontaneous loss, elective termination, ectopic pregnancy, complication of pregnancy (pre-eclampsia, gestational diabetes)

    2. Status of infant at delivery [At delivery]

      Collection of data on gender; gestational age; Apgar score and birth weight

    3. Details of any hospitalisations of infant, documented from delivery to 12 months of age. [From delivery to 12 months of age]

      Collection of hospitalisation reason, admission and discharge dates.

    4. Mode of delivery of infant [At delivery]

      Collection of delivery mode classified by caesarian section, normal vaginal delivery, operative vaginal delivery and vaginal breech delivery

    5. Growth of infant at 6 months post delivery [Between birth and 6 months of age]

      Data on infant growth measured by weight in kilograms.

    6. Details of any chronic medication taken by infant from birth to 12 months of age [From birth to 12 months of age]

      Details of any chronic medication prescribed to infant from birth to 12 months of age

    7. Developmental milestones measured at 6 and 12 months of age [At 6 and 12 months of age of infant]

      A check of developmental milestones made at 6 and 12 months of age. Details collected where expected milestones were not met.

    8. Details of any complication of delivery [At delivery]

      Recording the occurence of any complications of delivery as listed; requirement for blood transfusion, thromboembolism, fetal distress and amniotic fluid abnormality

    9. Growth of infant at 12 months post delivery [Between birth and 12 months of age]

      Data on infant growth measured by weight in kilograms.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    Exclusion Criteria:

    There are no exclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Camperdown New South Wales Australia 2050
    2 Research Site Clayton Victoria Australia 3168
    3 Research Site Graz Austria 8036
    4 Research Site Aalst Belgium 9300
    5 Research Site Edegem Belgium 2650
    6 Research Site La Louvière Belgium 7100
    7 Research Site Leuven Belgium 3000
    8 Research Site Liège Belgium 4000
    9 Research Site Hradec Kralove Czechia 500 05
    10 Research Site Liberec Czechia 460 63
    11 Research Site Praha 2 Czechia 128 08
    12 Research Site Uherske Hradiste Czechia 686 01
    13 Research Site Aarhus N Denmark 8200
    14 Research Site Athens Greece 11527
    15 Research Site Heraklion Greece 71110
    16 Research Site Ioannina Greece 45500
    17 Research Site Piraeus Greece 18536
    18 Research Site Cagliari Italy 09134
    19 Research Site Cinisello Balsamo (MI) Italy 20092
    20 Research Site Ferrara Italy 44124
    21 Research Site Genova Italy 16132
    22 Research Site Messina Italy 89125
    23 Research Site Milano Italy 20122
    24 Research Site Milano Italy 20162
    25 Research Site Modena Italy 41126
    26 Research Site Napoli Italy 80131
    27 Research Site Palermo Italy 90127
    28 Research Site Perugia Italy 06129
    29 Research Site Pisa Italy 56100
    30 Research Site Roma Italy 00161
    31 Research Site Amsterdam Netherlands 1105 AZ
    32 Research Site Rotterdam Netherlands 3015 CE
    33 Research Site Oslo Norway 0586
    34 Research Site Bratislava Slovakia 831 01
    35 Research Site Cordoba Andalucía Spain 14004
    36 Research Site Malaga Andalucía Spain 29010
    37 Research Site Zaragoza Aragón Spain 50009
    38 Research Site Hospitalet de Llobregat Cataluña Spain 08907
    39 Research Site Reus Cataluña Spain 43204
    40 Research Site Malmo Sweden 205 02
    41 Research Site Uppsala Sweden 751 85
    42 Research Site Geneva 14 Switzerland 1211
    43 Research Site Reinach Switzerland 4153
    44 Research Site Bournemouth United Kingdom BH7 7DW
    45 Research Site Cambridge United Kingdom CB2 0QQ
    46 Research Site Manchester United Kingdom M13 9WL
    47 Research Site Peterborough United Kingdom PE3 9GZ
    48 Research Site Stevenage United Kingdom SG1 4AB

    Sponsors and Collaborators

    • Amgen

    Investigators

    • Study Director: MD, Amgen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Amgen
    ClinicalTrials.gov Identifier:
    NCT02906124
    Other Study ID Numbers:
    • 20150162
    First Posted:
    Sep 19, 2016
    Last Update Posted:
    Dec 22, 2020
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Amgen
    hypercholesterolaemia
    Lipid lowering therapies
    Pregnancy
    Additional relevant MeSH terms:
    Hypercholesterolemia

    Study Results

    No Results Posted as of Dec 22, 2020