Study to Evaluate the Safety of Repatha® in Pregnancy

Terminated

• Conditions: Hypercholesterolaemia; Pregnancy

• Registration Number: NCT02906124
• Lead Sponsor: Amgen

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

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 Timeline

• Study First Submitted: 2016-08-01
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-19
• Study Start: 2017-01-12
• Primary Completion: 2020-11-06
• Study Completion: 2020-11-06
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-21
• Last Update Posted: 2020-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Status of infant at delivery	At delivery	Collection of data on gender; gestational age; Apgar score and birth weight
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
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
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.
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)
Growth of infant at 6 months post delivery	Between birth and 6 months of age	Data on infant growth measured by weight in kilograms.
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.
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
Growth of infant at 12 months post delivery	Between birth and 12 months of age	Data on infant growth measured by weight in kilograms.

Trial Locations

Locations (1)

Research Site; 🇬🇧 Stevenage, United Kingdom