Terminated/Withdrawn
Sponsor ID
20150162
Study to Evaluate the Safety of Repatha® in Pregnancy
Study Details
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
Protocol Summary
Primary Outcome Measures
Any incident of congenital anomaly
Timeframe: From birth up to 12 months of age
Secondary Outcome Measures
End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth
Timeframe: From pregnancy diagnosis through to birth
Status of infant at delivery
Timeframe: At delivery
Details of any hospitalisations of infant, documented from delivery to 12 months of age.
Timeframe: From delivery to 12 months of age
Mode of delivery of infant
Timeframe: At delivery
Growth of infant at 6 months post delivery
Timeframe: Between birth and 6 months of age
Details of any chronic medication taken by infant from birth to 12 months of age
Timeframe: From birth to 12 months of age
Developmental milestones measured at 6 and 12 months of age
Timeframe: At 6 and 12 months of age of infant
Details of any complication of delivery
Timeframe: At delivery
Growth of infant at 12 months post delivery
Timeframe: Between birth and 12 months of age
Locations
Location
Research Site
Uherske Hradiste, Czech Republic, 686 01
Status
Recruiting
Location
Research Site
Amsterdam, Netherlands, 1105 AZ
Status
Recruiting
Location
Research Site
Uppsala, Sweden, 751 85
Status
Recruiting
Location
Research Site
Bratislava, Slovakia, 831 01
Status
Recruiting
Location
Research Site
Aalst, Belgium, 9300
Status
Recruiting
Location
Research Site
La Louvière, Belgium, 7100
Status
Recruiting
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