A Multinational Observational Study to Evaluate the Safety of Repatha® in Pregnancy (20150162)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Scope is to evaluate the safety of Repatha in pregnancy, primary scope is to describe outcomes of pregnancy in FH women exposed to Repatha
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  REPATHA
• Study drug International non-proprietary name (INN) or common name:
  EVOLOCUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (C10AX13) evolocumab

  evolocumab
• Medical condition to be studied:
  Hypercholesterolaemia

Population studied

• Short description of the study population:
  Sunjects were females diagnosed with Familial hypercholesterolaemia with a confirmed pregnancy during the study observation period and who provided informed consent to follow-up in this study, for themselves and their infants born during the study observation period.; ; Inclusion Criteria; 1. Females diagnosed with FH; 2. Confirmed pregnancy during the study observation period; 3. Pregnancies identified retrospectively but within the study period will be included; 4. Multiple pregnancies, occurring in the same woman within the study period, will all be included (as separate pregnancies); 5. 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
• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  300

Study design details

• Main study objective:
  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
• Outcomes:
  The primary outcome measure is congenital anomaly. Any incidence of congenital anomaly will be diagnosed and classified by the study site investigator, or by the subject’s treating physician (eg. An obstetrician, paediatrician, neonatologist) if this is not the investigator, and reported on the study specific eCRF. • Pregnancy outcomes (live birth(s),stillbirth,spontaneous loss,elective termination,ectopic pregnancy,complications of pregnancy• Delivery outcomes (mode of delivery, complications including requirement for blood transfusion, thromboembolism, fetal distress, amniotic fluid abnormality)• Infant status at delivery• Infant outcomes at 6 and 12 months post-delivery
• Data analysis plan:
  Statistical analyses will be descriptive only. No statistical inference or imputations of missing data are planned.Subject demographics and baseline characteristics will be summarised. Summary statistics for continuous variables will include the number of subjects, mean, median, standard deviation or standard error, minimum, and maximum. For categorical variables, the frequency and percentage will be reported.Collection of study data may be both retrospective and/or prospective, depending on the time of enrolment of each study subject during the study observation period. Data obtained from retrospective and prospective subject identification will be reported separately.

Documents

Study results

20150162_Abstract Observational Research Study Report Published Report