ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Evaluate the Safety of Repatha® in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02906124
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : December 13, 2018
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
To evaluate outcomes of pregnancy in 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
Hypercholesterolaemia Pregnancy

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 Type : Observational
Estimated Enrollment : 300 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 : January 12, 2017
Estimated Primary Completion Date : June 19, 2026
Estimated Study Completion Date : June 19, 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Evolocumab

Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    Live birth(s), still birth, spontaneous loss, elective termination, ectopic pregnancy, complication of pregnancy (pre-eclampsia, gestational diabetes)

  2. Status of infant at delivery [ Time Frame: 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. [ Time Frame: From delivery to 12 months of age ]
    Collection of hospitalisation reason, admission and discharge dates.

  4. Mode of delivery of infant [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Between birth and 12 months of age ]
    Data on infant growth measured by weight in kilograms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Sites in Europe, South Africa and Australia where pregnant familial hypercholesterolaemia (FH) Patients are treated with and without Repatha®
Criteria

Inclusion Criteria:

  • Females diagnosed with Familial hypercholesterolaemia (FH).
  • Confirmed pregnancy during the study observation period.
  • 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


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): NCT02906124


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

  Show 46 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen

Additional Information:
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02906124     History of Changes
Other Study ID Numbers: 20150162
First Posted: September 19, 2016    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
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

Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Amgen:
hypercholesterolaemia
Lipid lowering therapies
Pregnancy

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs