Study to Evaluate the Safety of Repatha® in Pregnancy

Pregnancy Clinical Trial

Official title:

A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02906124
• Other study ID #: 20150162
• Status: Terminated
• Start date: January 12, 2017
• Est. completion date: November 6, 2020

Study information

• Verified date: December 2020
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: November 6, 2020
• Est. primary completion date: November 6, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolaemia
• Hypercholesterolemia
• Pregnancy

Locations

Country	Name	City	State
Australia	Research Site	Camperdown	New South Wales
Australia	Research Site	Clayton	Victoria
Austria	Research Site	Graz
Belgium	Research Site	Aalst
Belgium	Research Site	Edegem
Belgium	Research Site	La Louvière
Belgium	Research Site	Leuven
Belgium	Research Site	Liège
Czechia	Research Site	Hradec Kralove
Czechia	Research Site	Liberec
Czechia	Research Site	Praha 2
Czechia	Research Site	Uherske Hradiste
Denmark	Research Site	Aarhus N
Greece	Research Site	Athens
Greece	Research Site	Heraklion
Greece	Research Site	Ioannina
Greece	Research Site	Piraeus
Italy	Research Site	Cagliari
Italy	Research Site	Cinisello Balsamo (MI)
Italy	Research Site	Ferrara
Italy	Research Site	Genova
Italy	Research Site	Messina
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Modena
Italy	Research Site	Napoli
Italy	Research Site	Palermo
Italy	Research Site	Perugia
Italy	Research Site	Pisa
Italy	Research Site	Roma
Netherlands	Research Site	Amsterdam
Netherlands	Research Site	Rotterdam
Norway	Research Site	Oslo
Slovakia	Research Site	Bratislava
Spain	Research Site	Cordoba	Andalucía
Spain	Research Site	Hospitalet de Llobregat	Cataluña
Spain	Research Site	Malaga	Andalucía
Spain	Research Site	Reus	Cataluña
Spain	Research Site	Zaragoza	Aragón
Sweden	Research Site	Malmo
Sweden	Research Site	Uppsala
Switzerland	Research Site	Geneva 14
Switzerland	Research Site	Reinach
United Kingdom	Research Site	Bournemouth
United Kingdom	Research Site	Cambridge
United Kingdom	Research Site	Manchester
United Kingdom	Research Site	Peterborough
United Kingdom	Research Site	Stevenage

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Czechia,  Denmark,  Greece,  Italy,  Netherlands,  Norway,  Slovakia,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any incident of congenital anomaly	Any incidence of congenital anomaly recorded on the study specific eCRF	From birth up to 12 months of age
Secondary	End product of pregnancy summarised within 3 main categories: Fetal death, termination of pregnancy and live birth	Live birth(s), still birth, spontaneous loss, elective termination, ectopic pregnancy, complication of pregnancy (pre-eclampsia, gestational diabetes)	From pregnancy diagnosis through to birth
Secondary	Status of infant at delivery	Collection of data on gender; gestational age; Apgar score and birth weight	At delivery
Secondary	Details of any hospitalisations of infant, documented from delivery to 12 months of age.	Collection of hospitalisation reason, admission and discharge dates.	From delivery to 12 months of age
Secondary	Mode of delivery of infant	Collection of delivery mode classified by caesarian section, normal vaginal delivery, operative vaginal delivery and vaginal breech delivery	At delivery
Secondary	Growth of infant at 6 months post delivery	Data on infant growth measured by weight in kilograms.	Between birth and 6 months of age
Secondary	Details of any chronic medication taken by infant from birth to 12 months of age	Details of any chronic medication prescribed to infant from birth to 12 months of age	From birth to 12 months of age
Secondary	Developmental milestones measured at 6 and 12 months of age	A check of developmental milestones made at 6 and 12 months of age. Details collected where expected milestones were not met.	At 6 and 12 months of age of infant
Secondary	Details of any complication of delivery	Recording the occurence of any complications of delivery as listed; requirement for blood transfusion, thromboembolism, fetal distress and amniotic fluid abnormality	At delivery
Secondary	Growth of infant at 12 months post delivery	Data on infant growth measured by weight in kilograms.	Between birth and 12 months of age

External Links

•   AmgenTrials clinical trials website