Study to Evaluate the Safety of Repatha® in Pregnancy
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|ClinicalTrials.gov Identifier: NCT02906124|
Recruitment Status : Recruiting
First Posted : September 19, 2016
Last Update Posted : August 31, 2018
|Condition or disease|
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|
|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|
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
- 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
- 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)
- Status of infant at delivery [ Time Frame: At delivery ]Collection of data on gender; gestational age; Apgar score and birth weight
- 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.
- 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
- 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.
- 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
- 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.
- 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
- 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.
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
|Contact: Amgen Call Centerfirstname.lastname@example.org|
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